Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05025410
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma;Uterus; Polyp Endometrium; Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle	Drug: Remimazolam

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study
• Actual Study Start Date: Nov 1, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
General anesthesia using remimazolam and remifentanil Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil	Drug: Remimazolam; Loading for anesthesia induction: Remimazolam 6 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring

Outcome Measures

Primary Outcome Measures

1. Remimazolam induction dose [During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway)]

2. Remimazolam maintenance dose [During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion)]

Secondary Outcome Measures

1. Use of rescue midazolam [During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)]

2. Use of rescue rocuronium [During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion)]

3. Use of flumazenil [During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyo-Seok Na, Principal investigator, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05025410
• Other Study ID Numbers: B-2109-706-301
• First Posted: Aug 27, 2021
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Apr 25, 2022