Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial

IntroductionThere is insufficient evidence regarding the efficacy and safety of remimazolam in elderly patients. Therefore, this study evaluated the differences in the anesthesia characteristics and perioperative hemodynamic profiles of elderly patients receiving total intravenous anesthesia with re...

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Main Authors: Keum Young So, Jihwan Park, Sang Hun Kim
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-11-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1265860/full
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author Keum Young So
Keum Young So
Jihwan Park
Sang Hun Kim
Sang Hun Kim
author_facet Keum Young So
Keum Young So
Jihwan Park
Sang Hun Kim
Sang Hun Kim
author_sort Keum Young So
collection DOAJ
description IntroductionThere is insufficient evidence regarding the efficacy and safety of remimazolam in elderly patients. Therefore, this study evaluated the differences in the anesthesia characteristics and perioperative hemodynamic profiles of elderly patients receiving total intravenous anesthesia with remimazolam or propofol.MethodsEighty-four patients aged >65 years with an American Society of Anesthesiologists physical status of I–III were randomly assigned to Group R (receiving remimazolam, n = 42) or Group P (receiving propofol, n = 42). In Group R, remimazolam was initiated at a rate of 6 mg/kg/h until loss of consciousness (LOC) was achieved and maintained at 1 mg/kg/h subsequently. In Group P, 1.0–1.5 mg/kg of propofol was injected for 1 min and maintained at 100 μg/kg/min subsequently. The maintenance infusion rate was adjusted to maintain an appropriate depth of anesthesia until the end of the surgery. The primary outcome was the time to LOC. The depth of anesthesia scores and hemodynamic profiles were recorded perioperatively.ResultsThe time to LOC was significantly longer in Group R (120 s) than in Group P (60 s) (p < 0.001). The time to eye-opening (Group R, 10 min; Group P, 10 min; p = 0.056), the incidence of maintenance of hemodynamic changes within 20% of the peri-anesthetic values, and treatments for hemodynamic instability did not differ significantly between the groups. The depth of anesthesia scores did not differ significantly between the groups; however, the scores were higher in Group R than those in Group P before endotracheal intubation. The hemodynamic parameters did not differ significantly at any time point. The time to extubation was longer in Group R (12 min) than that in Group P (10 min) (p = 0.007). Similarly, the time to discharge from the operating room was significantly longer in Group R (15 min) compared to Group P (12 min) (p = 0.018).ConclusionRemimazolam does not exhibit a comparable effect to propofol in terms of anesthesia induction and recovery. However, it demonstrates a similar effect to propofol regarding intraoperative anesthesia depth and hemodynamic profile in elderly patients undergoing remifentanil-based total intravenous anesthesia.
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spelling doaj.art-7eb629a9125442b48bae7dc97a393e7b2023-11-02T11:25:53ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-11-011010.3389/fmed.2023.12658601265860Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trialKeum Young So0Keum Young So1Jihwan Park2Sang Hun Kim3Sang Hun Kim4Department of Anesthesiology and Pain Medicine, Chosun University Hospital, Gwangju, Republic of KoreaDepartment of Anesthesiology and Pain Medicine, School of Medicine, Chosun University, Gwangju, Republic of KoreaDepartment of Anesthesiology and Pain Medicine, Chosun University Hospital, Gwangju, Republic of KoreaDepartment of Anesthesiology and Pain Medicine, Chosun University Hospital, Gwangju, Republic of KoreaDepartment of Anesthesiology and Pain Medicine, School of Medicine, Chosun University, Gwangju, Republic of KoreaIntroductionThere is insufficient evidence regarding the efficacy and safety of remimazolam in elderly patients. Therefore, this study evaluated the differences in the anesthesia characteristics and perioperative hemodynamic profiles of elderly patients receiving total intravenous anesthesia with remimazolam or propofol.MethodsEighty-four patients aged >65 years with an American Society of Anesthesiologists physical status of I–III were randomly assigned to Group R (receiving remimazolam, n = 42) or Group P (receiving propofol, n = 42). In Group R, remimazolam was initiated at a rate of 6 mg/kg/h until loss of consciousness (LOC) was achieved and maintained at 1 mg/kg/h subsequently. In Group P, 1.0–1.5 mg/kg of propofol was injected for 1 min and maintained at 100 μg/kg/min subsequently. The maintenance infusion rate was adjusted to maintain an appropriate depth of anesthesia until the end of the surgery. The primary outcome was the time to LOC. The depth of anesthesia scores and hemodynamic profiles were recorded perioperatively.ResultsThe time to LOC was significantly longer in Group R (120 s) than in Group P (60 s) (p < 0.001). The time to eye-opening (Group R, 10 min; Group P, 10 min; p = 0.056), the incidence of maintenance of hemodynamic changes within 20% of the peri-anesthetic values, and treatments for hemodynamic instability did not differ significantly between the groups. The depth of anesthesia scores did not differ significantly between the groups; however, the scores were higher in Group R than those in Group P before endotracheal intubation. The hemodynamic parameters did not differ significantly at any time point. The time to extubation was longer in Group R (12 min) than that in Group P (10 min) (p = 0.007). Similarly, the time to discharge from the operating room was significantly longer in Group R (15 min) compared to Group P (12 min) (p = 0.018).ConclusionRemimazolam does not exhibit a comparable effect to propofol in terms of anesthesia induction and recovery. However, it demonstrates a similar effect to propofol regarding intraoperative anesthesia depth and hemodynamic profile in elderly patients undergoing remifentanil-based total intravenous anesthesia.https://www.frontiersin.org/articles/10.3389/fmed.2023.1265860/fullefficacyelderly patienthemodynamicspropofolremimazolamsafety
spellingShingle Keum Young So
Keum Young So
Jihwan Park
Sang Hun Kim
Sang Hun Kim
Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
Frontiers in Medicine
efficacy
elderly patient
hemodynamics
propofol
remimazolam
safety
title Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
title_full Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
title_fullStr Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
title_full_unstemmed Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
title_short Safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy: a randomized controlled trial
title_sort safety and efficacy of remimazolam for general anesthesia in elderly patients undergoing laparoscopic cholecystectomy a randomized controlled trial
topic efficacy
elderly patient
hemodynamics
propofol
remimazolam
safety
url https://www.frontiersin.org/articles/10.3389/fmed.2023.1265860/full
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