Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence

NCT06385002 | Completed

• 1 other identifier: 2024-0158
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone.

Conditions

Gynecological Surgery

Outcome Measures

Primary Outcomes (2)

• time to emergence

  A comparison will be made between the time to emergence from anesthesia in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.

  Immediate after the end of general anesthesia

• time to tracheal extubation

  A comparison will be made between the time to tracheal extubation in patients receiving concurrent administration of sevoflurane and remimazolam versus those maintained on sevoflurane alone after surgery.

  Immediate after the end of general anesthesia

Secondary Outcomes (5)

• usage of vasopressors

  During general anesthesia

• severity of cough

  immediate after the end of general anesthesia

• time to discharge from the recovery room

  immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more

• postoperative pain scores

  Immediate after entering the PACU, 15 minutes after entering the PACU

• scores for postoperative nausea and vomiting

  Immediate after entering the PACU, 15 minutes after entering the PACU

Study Arms (2)

Sevoflurane group, S group

NO INTERVENTION

The control group will maintain oxygen-air (O2-Air) at 2 L/min and adjust the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60.

Remimazolam/Sevoflurane group, RS group

ACTIVE COMPARATOR

After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60.

Drug: Remimazolam

Interventions

Remimazolam DRUG

After tracheal intubation, the experimental group will maintain oxygen-air (O2-Air) at 2 liters/minute, and remimazolam will be infused at 1.0mg/kg/h, while adjusting the concentration of sevoflurane to maintain the depth of anesthesia with a bispectral index (BIS) of 40-60.

Also known as: Byfavo

Remimazolam/Sevoflurane group, RS group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia
• Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II
• According to the American Society of Anesthesiologists (ASA) physical status classification:
• Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation

You may not qualify if:

• Patients classified as ASA physical status classification III or above
• Pregnant women
• Patients with hypersensitivity to sevoflurane or other halogenated anesthetics, malignant hyperthermia, or a history of it in the patient or family
• Patients with preoperative impairment of consciousness or coma
• Patients undergoing emergency surgery or those who are hemodynamically unstable preoperatively
• Patients with a history of neuromuscular disorders or medication affecting neuromuscular function
• Patients who have taken sedatives (anxiolytics, hypnotics, antipsychotics, antidepressants, or sleeping pills) within 24 hours
• Patients receiving long-term benzodiazepine therapy
• Patients with alcohol or substance dependence
• Patients with allergy history to benzodiazepines or flumazenil
• Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Patients with severe hypersensitivity reactions to dextran 40
• Patients with chronic renal failure requiring hemodialysis
• Patients with a history of acute angle-closure glaucoma

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Interventions

remimazolam

Study Officials

• Hee Young Kim, MD, PhD

  Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor for fund

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 25, 2024
• Study Start: July 31, 2023
• Primary Completion: August 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

KR (1)