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1,497 result(s) for "Conscious Sedation - methods"
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Efficacy and safety of Ciprofol for procedural sedation and anesthesia in non-operating room settings
Ciprofol, a novel intravenous anesthetic, provides rapid recovery in patients undergoing colonoscopy. We aimed to examine the efficacy and safety of ciprofol in comparison with propofol for sedation or anesthesia in non-operating room settings including endoscopic submucosal dissection, endoscopic retrograde cholangiopancreatography, and flexible bronchoscopy (FB). Prospective, randomized, double-blind, parallel-group clinical trial. University-affiliated teaching hospital. We recruited 207 patients scheduled for an endoscopic procedure from October 2021 to December 2021. Patients were randomized into three groups according to the dose during induction (n = 69 each): 1) ciprofol 6 mg/kg/h, 2) ciprofol 8 mg/kg/h, or 3) propofol 40 mg/kg/h. Ciprofol or propofol was administered throughout the procedure. The primary outcome was the success rate of sedation or anesthesia for the procedures. Secondary outcomes included induction time, endoscope insertion time, recovery time, discharge time, incidence of drug-related adverse events (AEs), neurological and inflammatory outcomes. The procedure success rates in the three groups were 100%. The induction time in the 6 (3.3 ± 1.0 min) and 8 mg/kg/h (2.9 ± 0.6 min) ciprofol groups was longer than that in the propofol group (2.5 ± 0.6 min) only in patients undergoing FB (p = 0.004). The time for patients to be fully alert and discharged from the post-anesthesia care unit was comparable across the three groups (p > 0.05). The incidence of drug-related AEs in the propofol and 6 and 8 mg/kg/h ciprofol groups was 84.1%, 76.8%, and 79.7%. No pain on injection was reported by ciprofol groups. Neurological outcomes and inflammatory responses were comparable among the three groups. Ciprofol induced a level of sedation or anesthesia equivalent to that induced by propofol in non-operating room settings except for a prolonged induction time in patients undergoing FB. Ciprofol had a safety profile similar to that of propofol. No pain on injection was reported by ciprofol. •Ciprofol, a novel intravenous anesthetic, and propofol induced equivalent sedation or anesthesia in non-operating room settings.•Ciprofol had a similar safety profile to that of propofol.•No pain on injection was reported by the ciprofol groups.•Ciprofol and propofol anesthesia had similar neurological outcomes and inflammatory parameters.
Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis
The agent that should be used for light sedation of patients requiring mechanical ventilation is unclear. This randomized trial compared dexmedetomidine with propofol for the light sedation of critically ill patients with sepsis who required mechanical ventilation. No clinically important differences were found.
A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures
In many countries, the combination of propofol and opioid is used as the preferred sedative regime during ERCP. However, the most serious risks of propofol sedation are oxygen deficiency and hypotension. Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, and to achieve widespread acceptance for procedural sedation, remimazolam must replace propofol which is the most commonly used for procedural sedation. The objective of this study was to compare the safety and efficacy profiles of the remimazolam and propofol when combined with alfentanil for sedation during ERCP procedures. A randomized, controlled, single-center trial. The Endoscopic Centre of Tianjin Nankai Hospital, China. 518 patients undergoing elective ERCP under deep sedation. Patients scheduled for ERCP were randomly assigned to be sedated with either a combination of remimazolam-alfentanil or propofol-alfentanil. The primary outcome was the prevalence of hypoxia, which was defined as SpO2 < 90% for >10 s. Other outcomes were the need for airway maneuver, procedure, and sedation-related outcomes and side effects (e.g., nausea, vomiting, and cardiovascular adverse events). A total of 518 patients underwent randomization. Of these, 250 were assigned to the remimazolam group and 255 to the propofol group. During ERCP, 9.6% of patients in the remimazolam group showed hypoxia, while in the propofol group, 15.7% showed hypoxia (p = 0.04). The need for airway maneuvering due to hypoxia was significantly greater in the propofol group (p = 0.04). Furthermore, patients sedated with remimazolam had a lower percentage of hypotension than patients sedated with propofol (p < 0.001). Patients receiving remimazolam sedation expressed higher satisfaction scores and were recommended the same sedation for the next ERCP. The procedure time in the remimazolam group was much longer than in the propofol group due to the complexity of the patient's disease, which resulted in a longer sedation time. During elective ERCP, patients administered with remimazolam showed fewer respiratory depression events under deep sedation with hemodynamic advantages over propofol when administered in combination with alfentanil. •The combination of propofol and an opioid is the preferred sedative regime during ERCP.•The major concerns with propofol sedation include oxygen desaturation and hypotension.•Patients administered with remimazolam showed fewer respiratory depression events and hemodynamic advantages over propofol.•These results may provide more options for ERCP sedation.
Sedation with Propofol for Routine ERCP in High-Risk Octogenarians: A Randomized, Controlled Study
Adequate patient sedation is mandatory for diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). In this respect it is known that the short-acting anesthetic propofol offers certain potential advantages for sedation during ERCP, but there are no controlled studies concerning the feasibility and safety of propofol sedation in elderly, high-risk patients. One hundred and fifty consecutive patients aged >or=80 yr with high comorbidity (ASA score >or=III: 91 %), randomly received midazolam plus meperidine (n = 75) or propofol alone (n = 75) for sedation during ERCP. Vital signs were continuously monitored and procedure-related parameters, recovery time, and quality as well as patients' cooperation and tolerance of the procedure were assessed. Clinically relevant changes in vital signs were observed at comparable frequencies with a temporary oxygen desaturation (<90%) occurring in eight patients in the propofol-group and seven patients receiving midazolam/meperidine (n.s.). Hypotension was documented in two patients in the propofol group and one patient receiving midazolam/meperidine. Propofol provided a significantly better patient cooperation than midazolam/meperidine (p < 0.01), but the procedure tolerability was rated nearly the same by both groups. Mean recovery time was significantly shorter in the propofol group (22 +/- 7 min vs 31 +/- 8 min for midazolam/meperidine (p < 0.01)) while the recovery score was significantly higher under propofol (8.3 +/- 1.2 vs 6.1 +/- 1.1(p < 0.01)). During recovery a significant lower number of desaturation events (<90%) were observed in the propofol group (12%) than in the midazolam/meperidine group (26%, p < 0.01). Under careful monitoring the use of propofol for sedation during ERCP is superior to midazolam/meperidine even in high-risk octogenarians.
Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial
Long-term complications of critical illness include intensive care unit (ICU)-acquired weakness and neuropsychiatric disease. Immobilisation secondary to sedation might potentiate these problems. We assessed the efficacy of combining daily interruption of sedation with physical and occupational therapy on functional outcomes in patients receiving mechanical ventilation in intensive care. Sedated adults (≥18 years of age) in the ICU who had been on mechanical ventilation for less than 72 h, were expected to continue for at least 24 h, and who met criteria for baseline functional independence were eligible for enrolment in this randomised controlled trial at two university hospitals. We randomly assigned 104 patients by computer-generated, permuted block randomisation to early exercise and mobilisation (physical and occupational therapy) during periods of daily interruption of sedation (intervention; n=49) or to daily interruption of sedation with therapy as ordered by the primary care team (control; n=55). The primary endpoint—the number of patients returning to independent functional status at hospital discharge—was defined as the ability to perform six activities of daily living and the ability to walk independently. Therapists who undertook patient assessments were blinded to treatment assignment. Secondary endpoints included duration of delirium and ventilator-free days during the first 28 days of hospital stay. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00322010. All 104 patients were included in the analysis. Return to independent functional status at hospital discharge occurred in 29 (59%) patients in the intervention group compared with 19 (35%) patients in the control group (p=0·02; odds ratio 2·7 [95% CI 1·2–6·1]). Patients in the intervention group had shorter duration of delirium (median 2·0 days, IQR 0·0–6·0 vs 4·0 days, 2·0–8·0; p=0·02), and more ventilator-free days (23·5 days, 7·4–25·6 vs 21·1 days, 0·0–23·8; p=0·05) during the 28-day follow-up period than did controls. There was one serious adverse event in 498 therapy sessions (desaturation less than 80%). Discontinuation of therapy as a result of patient instability occurred in 19 (4%) of all sessions, most commonly for perceived patient-ventilator asynchrony. A strategy for whole-body rehabilitation—consisting of interruption of sedation and physical and occupational therapy in the earliest days of critical illness—was safe and well tolerated, and resulted in better functional outcomes at hospital discharge, a shorter duration of delirium, and more ventilator-free days compared with standard care. None.
The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial
Propofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy. Randomized clinical trial. Single-centre, class A tertiary hospital, November 2021 to November 2022. Adult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m−2 patients scheduled to undergo colonoscopy. Consecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P). The primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events. No significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference − 1.2%, 95% CI: −6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001). Ciprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg−1 dose of ciprofol proved to be equal to a 2.0 mg kg−1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure. •Compared to the combination of ciprofol and opioids, ciprofol alone can still achieve a high success rates of colonoscopy.•Both are similar in efficacy, but ciprofol has a higher safety profile that making it more suitable for colonoscopy.•Less side effects and higher patient satisfaction of ciprofol compared with propofol.
Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients
In a randomized trial involving 700 mechanically ventilated ICU patients, 90-day mortality did not differ significantly between those assigned to a plan of no sedation and those assigned to a plan of light sedation with daily interruption. There was a low number of thromboembolic events, but they were more numerous in the sedation group.
Efficacy and Safety of the Remimazolam-Alfentanil Combination for Sedation During Gastroscopy: A Randomized, Double-blind, Single-center Controlled Trial
Propofol infusion is a popular single drug of choice for sedation in the gastrointestinal endoscopy suite. Drug combinations are more beneficial than single-drug regimens in gastroscopy sedation. However, the cardiopulmonary complications of propofol sedation raise concern. Remimazolam is a novel, ultra-short-acting benzodiazepine sedative, and alfentanil is a weak opioid. During endoscopic procedures, remimazolam is an effective and safe sedative procedure. No synergistic effect has been reported when remimazolam was combined with alfentanil in gastroscopy sedation. Here, we evaluated the effective dose, sedative efficacy, and safety of the remimazolam-alfentanil combination in gastroscopy sedation and compared the results with those of the propofol-alfentanil combination. This study was conducted in two parts. In Part 1, Dixon's up-and-down method (sequential distribution) was adopted for determining the 95% effective dose (ED95) (95% CI) and 95% CI of remimazolam combined with 5 µg/kg alfentanil. In Part 2, after obtaining the predictive remimazolam ED95, 161 patients were randomized into the remimazolam group (remimazolam-alfentanil) and the propofol group (propofol-alfentanil). The effectiveness of the drug combinations was measured according to successful sedation parameters. Changes in vital signs and the appearance of adverse events were used to assess the safety of drug combinations. Evaluation of patient and physician satisfaction was included as quality indicators of treatment. Baseline demographic and clinical characteristics were comparable between the 2 parts of the study. The ED95 of remimazolam in inhibiting a positive response to gastroscopy placement into the pharyngeal cavity was 0.33 mg/kg (95% CI, 0.289 to 1.023). The procedure success rate was 97.53% in the remimazolam group and 97.50% in the propofol group. The difference in the success rate of the procedure between the remimazolam and propofol groups was 0.03% (95% CI, –2.5 to 2.4). However, the incidence of injection pain, hypotension, respiratory depression, and dizziness was lower in the remimazolam group compared with the propofol group (P < 0.05). Furthermore, patients from the propofol group were more likely to be drowsy, and their work efficiency was reduced the day after leaving the hospital, whereas patients in the remimazolam group were less affected (P < 0.05). The ED95 of remimazolam was 0.33 mg/kg when it was combined with alfentanil (5 µg/kg) for gastroscopy sedation. The sedation strategy of remimazolam-alfentanil has noninferior efficacy, fewer adverse effects, and a better postoperative recovery process than propofol-alfentanil for patients undergoing gastroscopy. Chinese Clinical Trials Registry identifier: ChiCTR2100051565.
Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting
Dexmedetomidine (Dexdor ® ) is a highly selective α 2 -adrenoceptor agonist. It has sedative, analgesic and opioid-sparing effects and is suitable for short- and longer-term sedation in an intensive care setting. In the randomized, double-blind, multicentre MIDEX and PRODEX trials, longer-term sedation with dexmedetomidine was noninferior to midazolam and propofol in terms of time spent at the target sedation range, as well as being associated with a shorter time to extubation than midazolam or propofol, and a shorter duration of mechanical ventilation than midazolam. Patients receiving dexmedetomidine were also easier to rouse, more co-operative and better able to communicate than patients receiving midazolam or propofol. Dexmedetomidine had beneficial effects on delirium in some randomized, controlled trials (e.g. patients receiving dexmedetomidine were less likely to experience delirium than patients receiving midazolam, propofol or remifentanil and had more delirium- and coma-free days than patients receiving lorazepam). Intravenous dexmedetomidine had an acceptable tolerability profile; hypotension, hypertension and bradycardia were the most commonly reported adverse reactions. In conclusion, dexmedetomidine is an important option for sedation in the intensive care setting.
Effect of moderate versus deep sedation on recovery following outpatient gastroscopy in older patients: a randomized controlled trial
BackgroundAlthough gastrointestinal endoscopy with sedation is increasingly performed in older patients, the optimal level of sedation remains open to debate. In this study, our objective was to compare the effects of moderate sedation (MS) and deep sedation (DS) on recovery following outpatient gastroscopy in elderly patients.MethodsIn this randomized, partially blinded, controlled trial, we randomly divided 270 patients older than 60 years who were scheduled for elective outpatient gastroscopy into the MS or DS group based on the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. The primary outcome was the duration of stay in the post-anesthesia care unit (PACU). Secondary outcomes included the duration of the total hospital stay, frequency of retching, bucking, and body movements during the examination, endoscopist and patient satisfaction, and sedation-associated adverse events during the procedure.ResultsA total of 264 patients completed the study, of whom 131 received MS and 133 received DS. MS was associated with a shorter PACU stay [16.15 ± 9.01 min vs. 20.02 ± 11.13 min, P < 0.01] and total hospital stay [27.32 ± 9.86 min vs. 30.82 ± 12.37 min, P < 0.05], lesser hypoxemia [2.3% (3/131) vs. 12.8% (17/133), P < 0.01], use of fewer vasoactive drugs (P < 0.001), and more retching (P < 0.001). There was no difference in the incidence of bucking and body movements or endoscopist and patient satisfaction between the two groups.ConclusionCompared to deep sedation, moderate sedation may be a preferable choice for American Society of Anesthesiologists (ASA) Grade I–III elderly patients undergoing outpatient gastroscopies, as demonstrated by shorter PACU stays and total hospital stays, lower sedation-associated adverse events, and similar levels of endoscopist and patient satisfaction.