NCT05320016

Brief Summary

Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 30, 2022

Last Update Submit

April 6, 2022

Conditions

Day SurgeryPatient Outcome AssessmentQuality of RecoveryRemimazolam

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery

    the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)

    24 hours after ambulatory hysteroscopic surgery

Interventions

RemimazolamDRUG

Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery

Also known as: the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult woman scheduled for ambulatory gynecological surgery under general anesthesia

You may qualify if:

  • Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
  • American Society of Anesthesiology grade 1 or 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, 13620, South Korea

Location

MeSH Terms

Interventions

remimazolam

Study Officials

  • Sang-Hwan Do

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 11, 2022

Study Start

November 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)