Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

Completed

• Conditions: Myoma;Uterus; Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle; Polyp Endometrium
• Interventions: Drug: Remimazolam

• Registration Number: NCT05025410
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Study Start: 2021-11-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Adult woman scheduled for gynecological surgery under general anesthesia
• American Society of Anesthesiology grade 1 or 2
• When using a laryngeal mask airway to maintain general anesthesia

Exclusion Criteria

• Underlying diseases: liver, kidney, brain nervous system, glaucoma
• Patients with BMI greater than 30 and less than 18.5
• Patients diagnosed with sleep apnea
• Alcohol or drug dependent patients
• Patients with severe or acute respiratory failure
• Lactose intolerance
• Dextran 40 hypersensitivity
• Patients in shock or coma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General anesthesia using remimazolam and remifentanil	Remimazolam	Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil

Primary Outcome Measures

Name	Time	Method
Remimazolam induction dose	During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)
Remimazolam maintenance dose	During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)

Secondary Outcome Measures

Name	Time	Method
Use of rescue midazolam	During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of rescue rocuronium	During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)
Use of flumazenil	During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of