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"Intravenous anesthesia"
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Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: a pragmatic randomised triaL (VITAL)
2024
Background
Improving outcomes after surgery is a major public health research priority for patients, clinicians and the NHS. The greatest burden of perioperative complications, mortality and healthcare costs lies amongst the population of patients aged over 50 years who undergo major non-cardiac surgery. The Volatile vs Total Intravenous Anaesthesia for major non-cardiac surgery (VITAL) trial specifically examines the effect of anaesthetic technique on key patient outcomes: quality of recovery after surgery (quality of recovery after anaesthesia, patient satisfaction and major post-operative complications), survival and patient safety.
Methods
A multi-centre pragmatic efficient randomised trial with health economic evaluation comparing total intravenous anaesthesia with volatile-based anaesthesia in adults (aged 50 and over) undergoing elective major non-cardiac surgery under general anaesthesia.
Discussion
Given the very large number of patients exposed to general anaesthesia every year, even small differences in outcome between the two techniques could result in substantial excess harm. Results from the VITAL trial will ensure patients can benefit from the very safest anaesthesia care, promoting an early return home, reducing healthcare costs and maximising the health benefits of surgical treatments.
Trial registration
ISRCTN62903453. September 09, 2021.
Journal Article
Comparison of remimazolam-based and propofol-based total intravenous anesthesia on postoperative quality of recovery: A randomized non-inferiority trial
by
Choi, Jeong Yeon
,
Lee, Hye Sun
,
Song, Young
in
Anesthesia
,
Anesthesia Recovery Period
,
Anesthesia, General
2022
The quality of recovery (QoR) of remimazolam-based and propofol-based total intravenous anesthesia was compared as measured by QoR-15 scores.
A prospective, double-blind, randomized controlled, non-inferiority trial.
An operating room, a post-anesthesia care unit (PACU), and a hospital ward.
Female patients (n = 140; 20–65 years) scheduled for open thyroidectomy were enrolled and randomly assigned to the remimazolam or propofol group.
The remimazolam group received continuous remimazolam infusions and effect-site target-controlled remifentanil infusions. The propofol group received effect-site target-controlled infusions of propofol and remifentanil.
The primary outcome was QoR-15 on postoperative day 1 (POD1). The mean difference between the groups was compared against a non-inferiority margin of −8. Secondary outcomes were QoR-15 on POD2, hemodynamic data, time to lose and recover consciousness, sedation score upon PACU admission, pain, and postoperative nausea and vomiting profiles at the PACU and ward. Group-time interaction effects in hemodynamic data and QoR-15 were analyzed using a linear mixed model.
The total QoR-15 score on POD1 in the remimazolam group was non-inferior to that in the propofol group (mean [SD] 111.2 [18.8] vs. 109.1 [18.9]; mean difference [95% CI] 2.1 [−4.2, 8.5]; p = 0.002 for non-inferiority). The QoR-15 score on POD2 was comparable between the groups, and no group-time interaction was observed. At the end of anesthesia, after extubation, and upon arrival at the PACU, mean arterial pressure was significantly higher in the remimazolam group. Remimazolam group was more sedated at the time of admission to PACU. Pain intensity and the requirement for analgesics were lower in the remimazolam group than in the propofol group.
Remimazolam-based total intravenous anesthesia provided a similar QoR to propofol. Remimazolam and propofol can be used interchangeably for general anesthesia in female patients undergoing thyroid surgery.
•Evidence regarding quality of recovery after remimazolam-based total intravenous anesthesia has been limited.•Remimazolam-based total intravenous anesthesia was explored in female patients undergoing open thyroidectomy.•Remimazolam-based total intravenous anesthesia demonstrated similar quality of recovery to propofol.•Hypotensive incidence at cessation of anesthetics was lower in patients administered with remimazolam compared to propofol.•Remimazolam-based total intravenous anesthesia was associated with reduced pain intensity and analgesic requirement.
Journal Article
Effects of propofol/remifentanil-based total intravenous anesthesia versus sevoflurane-based inhalational anesthesia on the release of VEGF-C and TGF-β and prognosis after breast cancer surgery: a prospective, randomized and controlled study
2018
Background
Vascular endothelial growth factor (VEGF) and transforming growth factor-β (TGF-β) have been involved in tumor growth and metastasis. Sevoflurane may promote angiogenesis, whereas propofol can present an anti-angiogenic effect. In this study, we compared the effects of propofol/remifentanil-based total intravenous anesthesia (TIVA) and sevoflurane-based inhalational anesthesia on the release of VEGF-C and TGF-β, as well as recurrence- free survival (RFS) rates in the patients undergoing breast cancer surgery.
Methods
Eighty female patients undergoing breast cancer resection were enrolled and randomized to receive either sevoflurane-based inhalational anesthesia (SEV group) or propofol/remifentanil-based TIVA (TIVA group). The serum concentrations of VEGF-C and TGF-β before and 24 h after surgery were measured and RFS rates over a two-year follow-up were analyzed in both groups. The postoperative pain scores assessed using a visual analogue scale (VAS) and the use of perioperative opioids were also evaluated.
Results
Although VAS scores at 2 h and 24 h after surgery were comparable between the two groups, there were more patients receiving postoperative fentanyl in the TIVA group (16[40%]) compared with the SEV group (6[15%],
p
= 0.023). VEGF-C serum concentrations increased after surgery from 105 (87–193) pg/ml to174 (111–281) pg/ml in the SEV group (
P
= 0.009), but remained almost unchanged in the TIVA group with 134 (80–205) pg/ml vs.140(92–250) pg/ml(
P
= 0.402). The preoperative to postoperative change for VEGF-C of the SEV group (50 pg/ml) was significantly higher than that of the TIVA group (12 pg/ml) with a difference of 46 (− 11–113) pg/ml (
P
= 0.008). There were also no significant differences in the preoperative and postoperative TGF-β concentrations between the two groups. The two-year RFS rates were 78% and 95% in the SEV and TIVA groups (
P
= 0.221), respectively.
Conclusion
In comparison with sevoflurane-based inhalational anesthesia, propofol/remifentanil -based total intravenous anesthesia can effectively inhibit the release of VEGF-C induced by breast surgery, but didn’t seem to be beneficial in the short-term recurrence rate of breast cancer.
Trial registration
Chictr.org.cn
ChiCTR1800017910
. Retrospectively Registered (Date of registration: August 20, 2018).
Journal Article
A comparison between inhalational (Desflurane) and total intravenous anaesthesia (Propofol and dexmedetomidine) in improving postoperative recovery for morbidly obese patients undergoing laparoscopic sleeve gastrectomy: A double-blinded randomised controlled trial
by
Ibrahim, Ezzeldin
,
Elbakry, Abd-Elazeem
,
Sultan, Wesam-Eldin
in
Adult
,
Analgesics
,
Analgesics - therapeutic use
2018
Laparoscopic sleeve gastrectomy is commonly performed under total intravenous anaesthesia (TIVA) or balanced anaesthesia using an intravenous and inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study has been conducted to compare the use of the inhalation anaesthesia technique using desflurane with the TIVA technique, using propofol and dexmedetomidine.
Prospective, randomised, double-blinded study.
Menoufia Univeristy Hospital.
This randomised trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomised into two equally sized groups; one group received the inhalation anaesthesia technique and the other received the TIVA technique.
All patients received general anaesthesia, which was induced by propofol, remifentanil, and rocuronium. Anaesthesia was maintained using desflurane in oxygen air mixture in the inhalation group, whilst anaesthesia was maintained by intravenous infusion of propofol and dexmedetomidine in the TIVA group.
Intra-operative vital signs, anaesthesia recovery time, postoperative nausea and vomiting, pain score, post-anaesthetic care unit (PACU) stay time, total first 24h post-operative analgesic needs and the onset of first bowel movement were recorded.
Main results
The TIVA group had lower intra-operative heart rates and mean arterial blood pressure (P<0.0001). The TIVA group also had a lower post-operative visual analogue score for pain assessment (VAS) (P<0.0001), lower total analgesic requirements (P<0.0001), a lower incidence of nausea (P=0.01) and vomiting (P=0.03), and shorter PACU stays (P=0.01). There was no significant difference between groups with regard to the onset of bowel movement (P=0.16).
TIVA using propofol and dexmedetomidine is a better anaesthetic regimen than inhalation anaesthesia using desflurane for laparoscopic sleeve gastrectomy in morbidly obese patients. The TIVA technique provided better postoperative recovery with fewer postoperative side effects and analgesic requirements.
NCT03029715.
•TIVA using propofol and dexmedetomidine is a safe anaesthetic technique for morbidly obese undergoing sleeve gastrectomy.•TIVA technique can maintain a stable intraoperative haemodynamics.•TIVA can provide better postoperative recovery with fewer postoperative side effects and analgesic requirements.
Journal Article
Bispectral index to guide induction of anesthesia: a randomized controlled study
2018
Background
It is unknown to what extent hypotension frequently observed following administration of propofol for induction of general anesthesia is caused by overdosing propofol. Unlike clinical signs, electroencephalon-based cerebral monitoring allows to detect and quantify an overdose of hypnotics. Therefore, we tested whether the use of an electroencephalon-based cerebral monitoring will cause less hypotension following induction with propofol.
Methods
Subjects were randomly assigned to a bispectral index (BIS)-guided (target range 40–60) or to a weight-related (2 mg.kg
− 1
) manual administration of propofol for induction of general anesthesia. The primary endpoint was the incidence of hypotension following the administration of propofol. Secondary endpoints included the degree of hypotension and correlations between BIS and drop in mean arterial pressure (MAP). Incidences were analyzed with Fisher’s Exact-test.
Results
Of the 240 patients enrolled into this study, 235 predominantly non-geriatric (median 48 years, 25th – 75th percentile 35–61 years) patients without severe concomitant disease (88% American Society of Anesthesiology physical status 1–2) undergoing ear, nose and throat surgery, ophthalmic surgery, and dermatologic surgery were analyzed. Patients who were manually administered propofol guided by BIS (
n
= 120) compared to those who were given propofol by weight (
n
= 115) did not differ concerning the incidence of hypotension (44% vs. 45%;
p
= 0.87). Study groups were also similar regarding the maximal drop in MAP compared to baseline (33% vs. 30%) and the proportion of hypotensive events related to all measurements (17% vs. 19%). Final propofol induction doses in BIS group and NON-BIS group were similar (1.93 mg/kg vs. 2 mg/kg). There was no linear correlation between BIS and the drop in MAP at all times (
r
< 0.2 for all) except for a weak one at 6 min (
r
= 0.221).
Conclusion
Results of our study suggest that a BIS-guided compared to a weight-adjusted manual administration of propofol for induction of general anesthesia in non-geriatric patients will not lower the incidence and degree of arterial hypotension.
Trial registration
German Registry of Clinical Trials (
DRKS00010544
), retrospectively registered on August 4, 2016.
Journal Article
The Effect of Total Intravenous Anesthesia and Inhalational Anesthesia on the Markers of Neuronal and Systemic Inflammation in Patients Undergoing Resection of Supratentorial Gliomas (TINSI Trial): Study Protocol for a Randomized Controlled Trial
by
Ravindranath, Sreeja
,
Keshavapisharady, Krishnakumar
,
Praveen, Ranganatha
in
Anesthesia
,
Anesthetics
,
Biological markers
2025
Brain tumors and craniotomy surgeries can induce both systemic and neuronal inflammation. Currently, there is a limited amount of literature addressing the influence of anesthetic agents on neuronal and systemic inflammation in neurosurgical settings and its impact on the occurrence of postoperative neurocognitive dysfunction (PND). Our primary objective is to assess the effects of propofol-based total intravenous anesthesia (TIVA) compared to sevoflurane inhalational anesthesia (INHA) with respect to the levels of perioperative inflammatory markers, specifically neuron-specific enolase (NSE) and interleukin-6 (IL-6) in patients undergoing craniotomy for supratentorial tumor surgery. Our secondary objective is to evaluate the correlation of neuronal, systemic inflammatory markers, and the incidence of PND and functional outcomes in patients receiving TIVA versus INHA for supratentorial tumor surgeries. This study protocol details the methodology of a prospective, randomized, and single-center trial approved by the Institutional Ethics Committee and registered with the Clinical Trial Registry of India. The study focuses on patients undergoing craniotomy for supratentorial glioma decompression. Assessing changes in the biomarker level is the primary objective and correlation of this change in biomarker with PND and functional outcome is our secondary objective. The sample size of 45 patients in each group was calculated using n master software by considering alpha of 5%, power of 80%, a mean difference of 79.2 between the groups, and an effect size of 0.603. We describe the study protocol of the single-center trial. The first patient was recruited on September 17, 2023, and we will complete recruitment before March 2025. Our study is expected to inform the impact of anesthesia technique on the biomarkers of the inflammation and consequently PND. Knowledge about this will help the anesthesiologist to select the appropriate anesthetic drug in their clinical practice.
Journal Article
Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial
by
Politi, Mary C
,
Mashour, George A
,
Vlisides, Philip E.
in
Administration, Intravenous
,
Adolescent
,
Adult
2023
IntroductionMillions of patients receive general anaesthesia for surgery annually. Crucial gaps in evidence exist regarding which technique, propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA), yields superior patient experience, safety and outcomes. The aim of this pilot study is to assess the feasibility of conducting a large comparative effectiveness trial assessing patient experiences and outcomes after receiving propofol TIVA or INVA.Methods and analysisThis protocol was cocreated by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 300-patient, two-centre, randomised, feasibility pilot trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to propofol TIVA or INVA, stratified by centre and procedural complexity. The feasibility endpoints include: (1) proportion of patients approached who agree to participate; (2) proportion of patients who receive their assigned randomised treatment; (3) completeness of outcomes data collection and (4) feasibility of data management procedures. Proportions and 95% CIs will be calculated to assess whether prespecified thresholds are met for the feasibility parameters. If the lower bounds of the 95% CI are above the thresholds of 10% for the proportion of patients agreeing to participate among those approached and 80% for compliance with treatment allocation for each randomised treatment group, this will suggest that our planned pragmatic 12 500-patient comparative effectiveness trial can likely be conducted successfully. Other feasibility outcomes and adverse events will be described.Ethics and disseminationThis study is approved by the ethics board at Washington University (IRB# 202205053), serving as the single Institutional Review Board for both participating sites. Recruitment began in September 2022. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.Trial registration numberNCT05346588.
Journal Article
Effects of total intravenous anesthesia with etomidate and propofol on postoperative cognitive dysfunction
2023
Increased incidence of postoperative cognitive dysfunction (POCD) is observed in elderly patients underwent intravenous anesthesia (TIVA) with endotracheal intubation. Modulation of anesthetics compatibility may reduce the severity of POCD. Elderly patients scheduled for TIVA with endotracheal intubation were randomly divided into the control group (1.00‑2.00 mg/kg propofol) and the etomidate and propofol combination group (1.00‑2.00 mg/kg propofol and 0.30 mg/kg etomidate). Serum cortisol, S100β, and neuron-specific enolase (NSE), interleukin (IL)-6, and IL-10 were monitored during or after the operation. Mini-mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) were utilized to assess the severity of POCD. 63 elderly patients in the etomidate and propofol combination group and 60 patients in the control group were enrolled, and there was no significant difference in gender, American Society of Anesthesiologists (ASA) physical status, surgical specialty, intraoperative blood loss, and operation time between the two groups. Significantly increased serum cortisol, S100β, NSE, IL-6, and reduced MMSE and MoCA scores were detected in the control group at different time points after the operation (0-72 h post operation) when compared to those before the operation. Similar trends for these observed factors were found in the etomidate and propofol combination group. In addition, the etomidate and propofol combination group showed better effects in reducing the serum levels of cortisol, S100β, NSE, IL-6, and increasing the MMSE and MoCA scores when compared to the control group. The present study demonstrates that the combination of propofol with etomidate could alleviate POCD in elderly patients underwent TIVA with endotracheal intubation anesthesia.
Journal Article
Postoperative quality of recovery comparison between ciprofol and propofol in total intravenous anesthesia for elderly patients undergoing laparoscopic major abdominal surgery: A randomized, controlled, double-blind, non-inferiority trial
2024
We conducted a non-inferiority study to assess the postoperative quality of recovery (QoR) in elderly patients receiving ciprofol or propofol total intravenous anesthersia(TIVA)after elective laparoscopic major abdominal surgery, with QoR-15 scores as the main measure.
A prospective, double-blind, randomized non-inferiority trial was conducted in the theater, post-anesthesia care unit (PACU), and the ward.
144 elderly patients (age ≥ 65 years) were randomly assigned to either the ciprofol group or the propofol group.
The ciprofol group received continuous infusion of ciprofol with remifentanil, and the propofol group received infusion of propofol with remifentanil.
The primary outcome was the QoR-15 on the first postoperative day (POD1), assessed in both intention-to-treat and per-protocol populations, with the mean difference between groups compared to a non-inferiority threshold of −8. Additional assessments included QoR-15 scores on POD2, 3, and 5 for both analysis sets. Other evaluated perioperative value factors included hemodynamic parameters and injection discomfort in the intention-to-treat analysis. A linear mixed model was utilized to examine the impact of group-time interactions on hemodynamic data and QoR-15.
The QoR-15 scores on POD1 in the ciprofol group were non-inferior to those in the propofol group both in intention-to-treat set (mean [95 %CI], 95.9[93.7–98.2] vs. 95.6 [93.3–97.8]; mean difference [95 % CI], 0.4 [−2.8–3.5]; P<0.001 for noninferiority) and per-protocol set (mean [95 %CI], 96.7 [94.4–99.0] vs. 95.7 [93.4–98.0]; mean difference [95 % CI], 1.0 [−2.2–4.3]; P<0.001 for noninferiority). Comparable outcomes were noted on postoperative days 2, 3, and 5 following the procedure in both analysis sets. Additionally: compared with propofol group, the occurrence of injection pain was lower (2.8 % vs. 27.8 %, P < 0.001); the hypotension was less frequent (33.3 % vs. 54.2 %, P = 0.012); the bradycardia was more common (38.9 % vs. 23.6 %, P = 0.048).
Ciprofol is not inferior to propofol in QoR. Ciprofol can be suitably administered to elderly patients undergoing elective laparoscopic major abdominal surgery.
•Ciprofol is a novel intravenous anesthetic agent.•Ciprofol offers a comparable quality of recovery to propofol, with reduced injection pain, more stable intraoperative hemodynamics.•For elderly patients with cardiovascular diseases undergoing major laparoscopic surgery, ciprofol may be preferable to propofol.
Journal Article
Effect of total intravenous anesthesia versus sevoflurane anesthesia on intraoperative facial nerve monitoring: a randomized controlled trial
2025
Intraoperative facial nerve monitoring (IFNM) facilitates effective nerve preservation during ear and head and neck surgeries. Quantitative differences in the timely feasibility of IFNM during total intravenous anesthesia (TIVA) vs sevoflurane anesthesia have not been investigated.
We conducted a randomized controlled trial in which 98 patients undergoing ear surgery were allocated to either the TIVA or sevoflurane group. We used quantitative neuromuscular monitoring of train-of-four (TOF) responses to assess achievements of IFNM-feasible conditions, and recorded the TOF count (TOFC) or TOF ratio of T4/T1 (TOFR). The primary outcome was the time interval between a TOFR of 0.25 and 0.75 (recovery index). The most important secondary outcome was the time to reach a TOFR of 0.25. We also recorded the quality of IFNM, intubation condition, patient-ventilator dyssynchrony, surgeon's satisfaction, and postoperative analgesic and antiemetic requirements.
Ninety-two patients completed the study. The median [interquartile range] recovery index was significantly shorter in the TIVA group (9 [7-11] min) than in the sevoflurane group (34 [24-53] min), with a difference in medians of 25 min (95% confidence interval, 20 to 31; P < 0.001). Before IFNM requests, the time to TOFR of 0.25 was achieved earlier in the TIVA group (34 [29-41] min) than in the sevoflurane group (51 [43-77] min) (P < 0.001). Both groups achieved neuromuscular recovery in time for IFNM without a need for reversal agents.
Intraoperative facial nerve monitoring was feasible earlier and faster under TIVA than under sevoflurane anesthesia. We suggest that TIVA may be a preferable choice over sevoflurane to meet a surgeon's request for an earlier IFNM.
CRIS.nih.go.kr ( KCT0006676 ); first submitted 7 October 2021.
Journal Article