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342 result(s) for "Deep Sedation - methods"
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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.
Anesthetist-Directed Sedation Favors Success of Advanced Endoscopic Procedures
Sedation is required to perform endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) given the duration and complexity of these advanced procedures. Sedation options include anesthetist-directed sedation (ADS) vs. gastroenterologist-directed sedation (GDS). Although ADS has been shown to shorten induction and recovery times, it is not established whether it impacts likelihood of procedure completion. Our aim was to assess whether ADS impacts the success of advanced endoscopy procedures. We prospectively assessed the sedation strategy for patients undergoing ERCP and EUS between October 2010 and October 2013. Although assignment to ADS vs. GDS was not randomized, it was determined by day of the week. A sensitivity analysis using propensity score matching was used to model a randomized trial. The main outcome, procedure failure, was defined as an inability to satisfactorily complete the ERCP or EUS such that an additional endoscopic, radiographic, or surgical procedure was required. Failure was further categorized as failure due to inadequate sedation vs. technical problems. During the 3-year study period, 60% of the 1,171 procedures were carried out with GDS and 40% were carried out with ADS. Failed procedures occurred in 13.0% of GDS cases compared with 8.9% of ADS procedures (multivariate odds ratio (OR): 2.4 (95% confidence interval (CI): 1.5-3.6)).This was driven by a higher rate of sedation failures in the GDS group, 7.0%, than in the ADS group, 1.3% (multivariate OR: 7.8 (95% CI: 3.3-18.8)). There was no difference in technical success between the GDS and ADS groups (multivariate OR: 1.2 (95% CI: 0.7-1.9)). We were able to match 417 GDS cases to 417 ADS cases based on procedure type, indication, and propensity score. Analysis of the propensity score-matched patients confirmed our findings of increased sedation failure (multivariate OR: 8.9 (95% CI: 2.5-32.1)) but not technical failure (multivariate OR: 1.2 (0.7-2.2)) in GDS compared with ADS procedures. Adverse events of sedation were rare in both groups. Failed ERCP in the GDS group resulted in a total of 93 additional days of hospitalization. We estimate that $67,891 would have been saved if ADS had been used for all ERCP procedures. No statistically significant difference in EUS success was identified, although this sub-analysis was limited by sample size. ADS improves the success of advanced endoscopic procedures. Its routine use may increase the quality and efficiency of these services.
The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation SPICE III Trial
Background Septic shock is associated with decreased vasopressor responsiveness. Experimental data suggest that central alpha2-agonists like dexmedetomidine (DEX) increase vasopressor responsiveness and reduce catecholamine requirements in septic shock. However, DEX may also cause hypotension and bradycardia. Thus, it remains unclear whether DEX is hemodynamically safe or helpful in this setting. Methods In this post hoc subgroup analysis of the Sedation Practice in Intensive Care Evaluation (SPICE III) trial, an international randomized trial comparing early sedation with dexmedetomidine to usual care in critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland. The primary outcome was vasopressor requirements in the first 48 h after randomization, expressed as noradrenaline equivalent dose (NEq [μg/kg/min] = noradrenaline + adrenaline + vasopressin/0.4). Results Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites. Eighty-three patients with septic shock were included in this subgroup analysis. Of these, 44 (53%) received DEX and 39 (47%) usual care. Vasopressor requirements in the first 48 h were similar between the two groups. Median NEq dose was 0.03 [0.01, 0.07] μg/kg/min in the DEX group and 0.04 [0.01, 0.16] μg/kg/min in the usual care group ( p  = 0.17). However, patients in the DEX group had a lower NEq/MAP ratio, indicating lower vasopressor requirements to maintain the target MAP. Moreover, on adjusted multivariable analysis, higher dexmedetomidine dose was associated with a lower NEq/MAP ratio. Conclusions In critically ill patients with septic shock, patients in the DEX group received similar vasopressor doses in the first 48 h compared to the usual care group. On multivariable adjusted analysis, dexmedetomidine appeared to be associated with lower vasopressor requirements to maintain the target MAP. Trial registration The SPICE III trial was registered at ClinicalTrials.gov ( NCT01728558 ).
Sedation and analgesia in post-cardiac arrest care: a post hoc analysis of the TTM2 trial
Background The routine use of sedation and analgesia during post-cardiac arrest care and its association with clinical outcomes remain unclear. This study aimed to describe the use of sedatives and analgesics in post-cardiac arrest care, and evaluate associations with good functional outcome, survival, clinical seizures, and late awakening. Methods This was a post hoc analysis of the TTM2-trial, which randomized 1900 out-of-hospital cardiac arrest patients to either normothermia or hypothermia. In both groups, deep sedation (Richmond Agitation and Sedation Scale ≤ -4) was mandatory during the 40-h intervention. Cumulative doses of sedatives and analgesic drugs were recorded within the first 72 h from randomization. Outcomes were functional outcome (modified Rankin Scale) and survival status at 6 months, occurrence of clinical seizures during the intensive care stay, and late awakening (Full outline of unresponsiveness motor score of four 96 h after randomization). Cumulative propofol doses were divided into quartiles (Q1-Q4). Logistic regression models were used to assess associations between sedative doses and functional outcome and survival, clinical seizures, and late awakening, adjusting for the severity of illness and other clinical factors influencing sedation. Results A total of 1861 patients were analyzed. In a multivariable logistic regression model, higher propofol doses (Q3, 100.7–153.6 mg/kg) were associated with good functional outcome (OR 1.62, 95%CI 1.12—2.34) and (Q2 and Q3, 43.9–153.6 mg/kg) with survival (OR 1.49, 95%CI 1.05—2.12 and OR 1.84, 95%CI 1.27—2.65, respectively). Receiving fentanyl and remifentanil were associated with good functional outcome (OR 1.69, 95%CI 1.27—2.26 and OR 1.50, 95%CI 1.11—2.02) and survival (OR 1.80, 95%CI 1.35—2.40 and OR 1.56, 95%CI 1.16—2.10). Receiving fentanyl (OR 0.64, 95%CI 0.48—0.86) and higher propofol doses (Q2-4 (43.9–669.4 mg/kg) were associated with the occurrence of clinical seizures. The highest quartile of propofol dose (153.7–669.4 mg/kg, OR 3.19, 95%CI 1.91—5.42) was associated with late awakening. Conclusions In this study, higher doses of propofol and the use of remifentanil and fentanyl were associated with good functional outcome and survival, occurrence of clinical seizures, and late awakening.
A comparison of the success rate of pneumatic reduction in intussusception between general anesthesia and deep sedation: a randomized controlled trial
Purpose This study was aimed to compare the success rate between patients who underwent general anesthesia and deep sedation. Methods Patients who were diagnosed with intussusception and had no contraindications would receive non-operative treatment first by undergoing pneumatic reduction. The patients were then split in to two groups: one group underwent general anesthesia (GA group), while the other underwent deep sedation (SD group). This study was a randomized controlled trial which compared success rate between two groups. Results A total of 49 episodes diagnosed with intussusception were random into 25 episodes in GA group and 24 episodes in SD group. There was no significant difference in baseline characteristic between the two groups. The success rates of GA group and SD group were equally 88.0% ( p = 1.00). Sub-analysis of the success rate was lower in the patients with high-risk score for failed reduction. (Chiang Mai University Intussusception (CMUI) failed score in success VS failed = 6.9 ± 3.2 vs. 10.3 ± 3.0 p  = 0.017). Conclusion General anesthesia and deep sedation offered similar success rates. In cases of high risk of failure, general anesthesia should be considered to accommodate the switch to surgical management in the same setting if the non-operative approach fails. The appropriate treatment and sedative protocol also increase the success of reduction.
Comparison of effect of remimazolam and propofol on respiration of patients under deep sedation for colonoscopy: a prospective multicenter randomized controlled trial
Background Remimazolam recently became available as a sedative. The comparison of the respiratory suppression effects of remimazolam and propofol under deep sedation for colonoscopy was not thoroughly unclear, particularly with regard to the novel metric of time to first airway intervention. The goal of this study was to systemically compare the respiration profiles of the patients sedated with remimazolam and propofol at the comparable sedation level in the patients undergoing colonoscopy. Methods Four hundred-fifty outpatients were randomly assigned to remimazolam (Group Rem, n  = 225) and propofol (Group Pro, n  = 225). The target sedation level was the modified Observer’s Assessment of Alertness/Sedation ≤ 2. The primary outcome was elapsed time from anesthesia induction to first airway intervention. Secondary outcomes included incidence and severity of hypoxia and apnea, minute ventilation (MV), tidal volume (TV), and respiratory rate (RR). Results The elapsed time from induction to the first airway intervention was 11 ± 8 min in Group Rem (n = 208) vs. 5 ± 6 min in Group Pro ( n  = 208, P  < 0.001). Patients in Group Rem required less frequent airway intervention and had a lower incidence of and shorter duration of apnea than patients in Group Pro (all P  < 0.001). MV at 1 min, 2 min, 4 min post-induction, and at the end of the procedure were higher in Group Rem than those in Group Pro ( P  < 0.001). Conclusions Patients sedated with remimazolam vs. propofol during colonoscopy maintain improved respiration and require less frequent airway intervention, and have lower incidence of adverse events. Clinical trial registration and registry URL ChiCTR2000034527, registered at www.chictr.org.cn
Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial
Background Remimazolam is a novel ultrashort-acting sedative and anesthetic drug. Numerous recent studies have demonstrated its sedative effect, however, research has yet to be conducted to explore the safety of remimazolam in deep sedation flexible fiberoptic bronchoscopy (FFB) in elderly patients. Methods Sixty-six elderly patients who underwent FFB were randomly assigned to either the remimazolam (Group R) or propofol (Group P) group. Initially, both groups received an intravenous injection of 10 µg/kg alfentanil. Subsequently, both groups were administered experimental drugs intravenously: (1) Group R received 0.2 mg/kg remimazolam, and (2) Group P received 1.5 mg/kg propofol. Throughout the FFB, patients were maintained in a state of deep sedation (modified observer’s assessment of alertness/sedation score ≤ 1) by titrating the experimental drugs as needed. The primary outcome measured was the incidence of hypoxemia during the FFB. Secondary outcomes included other safety outcomes, effectiveness outcomes, and procedural characteristics. Results Group R had a lower incidence of hypoxemia compared to Group P (9.1% vs. 45.5%) (RR, 0.20 [95% CI, 0.06–0.63], P  = 0.001). The Minimum SpO 2 and minimum MAP in Group R was higher than in Group P (93.1 ± 3.8 vs. 89.0 ± 6.7, P  = 0.004) (82.8 ± 12.4 vs. 72.8 ± 14.1, P  = 0.003); ΔMAP and ΔHR in Group R was lower than in Group P (15.9 ± 5.2 vs. 28.8 ± 12.4, P  < 0.001), (14.9 ± 3.2 vs. 17.8 ± 4.2, P  = 0.003); the incidence of hypotension in Group R was lower than in Group P (9.1% vs. 30.3%, P  = 0.030); the incidence of injection pain in Group R was lower than in Group P (0% vs. 27.3%, P  = 0.001). Conclusions During the maintenance of elderly patients under deep sedation with FFB, remimazolam exhibited superior safety than propofol, particularly in terms of respiratory depression and cardiovascular inhibition. Trial registration The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (clinical trial number: ChiCTR2400083383; Principal Investigator: Gongchen Duan; date of registration: 23 April 2024).
Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study
Background Fospropofol disodium is comparable to propofol in maintaining mild-to-moderate sedation for mechanically ventilated patients in intensive care unit (ICU). However, its efficacy for deep sedation remains unclear. Therefore, we conducted a randomized-controlled trial comparing the efficacy and safety of fospropofol disodium with propofol for deep sedation of mechanically ventilated patients in ICU. Methods In this randomized pilot study, critically ill adult patients requiring deep sedation were randomized to receive fospropofol disodium or propofol. The study drug was titrated to maintain a Richmond Agitation-Sedation Scale score (RASS) of−5 or−4. Narcotrend Index (NI) value was monitored during the whole study period. The primary outcome was the percentage of time in the target sedation range without rescue sedation. The secondary outcomes were successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, 28-day all-cause mortality and adverse events. Results Thirty patients were included in each group. The fospropofol disodium infusion lasted for 47.50 (IQR 31.75 to 48.00) hours at a dose of 8.19 ± 2.36 mg/kg/h, while propofol infusion for 48.00 (IQR 30.88 to 48.00) hours at 2.73 ± 0.83 mg/kg/h. The proportion of time within the target RASS range without rescue sedation was 96.78%±0.07% in the fospropofol group and 98.43%±0.04% in the propofol group ( p  = 0.273). A total of 39 patients experienced adverse events, with 19 in the fospropofol group and 20 in the propofol group. The most common adverse event was hypotension, with 18 patients (60.0%) in each group. No significant differences were observed in successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, or 28-day all-cause mortality. Conclusions In this open-label trial, fospropofol disodium achieved deep sedation at a rate comparable to propofol. For mechanically ventilated ICU patients, fospropofol disodium may offer a safe and effective sedation option. Larger multicenter trials are needed to confirm these findings. Trial registration The trial was registered on ClinicalTrials.gov on May 12, 2023, with the identifer NCT05870514.
A randomized controlled trial of light versus deep propofol sedation for elective outpatient colonoscopy: recall, procedural conditions, and recovery
Purpose This study aimed to determine if the incidence of recall was equivalent between light and deep sedation for colonoscopy. Secondary analysis included complications, patient clinical recovery, and post-procedure cognitive impairment. Methods Two hundred patients undergoing elective outpatient colonoscopy were randomized to light (bispectral index [BIS] 70-80) or deep (BIS < 60) sedation with propofol and fentanyl. Recall was assessed by the modified Brice questionnaire, and cognition at baseline and discharge was assessed using a Cogstate test battery. Results The median (interquartile range [IQR]) BIS values were different in the two groups (69 [65-74] light sedation vs 53 [46-59] deep sedation; P < 0.0001). The incidence of recall was 12% in the light sedation group and 1% in the deep sedation group. The risk difference for recall was 0.11 (90% confidence interval, 0.05 to 0.17) in the intention-to-treat analysis, thus refuting equivalence in recall between light and deep sedation (0.05 significance level; 10% equivalence margin). Overall sedation-related complications were more frequent with deep sedation than with light sedation (66% vs 47%, respectively; P = 0.008). Recovery was more rapid with light sedation than with deep sedation as determined by the mean (SD) time to reach a score of 5 on the Modified Observer’s Assessment of Alertness/Sedation Scale [3 (4) min vs 7 (4) min, respectively; P < 0.001] and by the median [IQR] time to readiness for hospital discharge (65 [57-80] min vs 74 [63-86] min, respectively; P = 0.001). The incidence of post-procedural cognitive impairment was similar in those randomized to light (19%) vs deep (16%) sedation ( P = 0.554). Conclusion Light sedation was not equivalent to deep sedation for procedural recall, the spectrum of complications, or recovery times. This study provides evidence to inform discussions with patients about sedation for colonoscopy. This trial was registered at the Australian and New Zealand Clinical Trials Registry, number 12611000320954.
Effect of esketamine vs sufentanil adjunct to propofol deep sedation on the incidence of oxygen-desaturation in elderly patients undergoing urologic surgeries: a randomized, double-blind, controlled trial
Background Propofol deep sedation/anesthesia combined with analgesics is always used in minimally invasive urologic surgeries in elderly patients.Oxygen-desaturation is one of the most frequent respiratory complications susceptible to other life-threatening accidents for elderly patients during propofol sedation. The purpose of this study is to evaluate the efficacy and safety of low-dose esketamine adjunct to propofol sedation on the occurrence of oxygen-desaturation, hypotension, propofol requirements and other related adverse events compared to sufentanil for elderly patients undergoing urologic surgeries. Methods Ninety four elderly male patients undergoing transurethral bladder lesion resection or ureteroscopic ureteral laser lithotripsy were randomly enrolled into esketamine/propofol group (SK group, n  = 47) or sufentanil/propofol group (SF group, n  = 47). The patients in SK group received 0.25 mg/kg esketamine and 1.5 mg/kg propofol for anesthetic induction and SF group received 0.1 μg/kg sufentanil and 1.5 mg/kg propofol. Sedation was Maintained with 4-6 mg/kg/h propofol infusion. The primary outcome was the incidence of oxygen-desaturation during the surgeries. Second outcomes included induction time, hemodynamic changes, intraoperative propofol dosage, operation duration and anesthesia duration, recovery time, other related adverse events and rescue medication. Results The incidence of oxygen-desaturation was 34.0% (16 of 47) in SK group compared to 68.1% (32 of 47) in SF group with a significant difference (risk ratio, 0.50; 95% confidence interval, 0.32–0.78; P  < 0.001). The overall severity of hypoxiemia was mild in SK group (22/9/16 vs 6/9/32, P  = 0.00072). Propofol requirements, induction time were all much lower in SK group than those in SF group ( P  < 0.001). More hemodynamic stability was observed in SK group compared to SF group. The protective factors of oxygen-desaturation were esketamine (OR:0.26, CI: 0.08 to 0.86, P  = 0.027), transurethral bladder lesion resection (OR:0.14, CI: 0.03 to 0.64, P  = 0.011). Weight was a hazard factor of OD (OR:1.07, CI: 1.00 to 1.15, P  = 0.048). Postoperative sedation score, MMSE, VAS score, incidence of nausea and vomiting were similar in both groups ( P  > 0.05). Conclusions Esketamine combined with propofol sedation used in minimal invasive urologic surgeries, could reduce the incidence of oxygen-desaturation, decrease propofol requirements, stabilize hemodynamics and didn’t affect the postoperative recovery and neurological function of elderly patients. Trial registration Chinese Clinical Trial Registry, No: ChiCTR2300077170. Registered on 1 November 2023. Prospective registration. http://www.chictr.org.cn . Graphical abstract