Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

NCT ID: NCT05320016

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

Conditions

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Day Surgery Patient Outcome Assessment Quality of Recovery Remimazolam

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Remimazolam

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-Hwan Do

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-2109-708-309

Identifier Type: -

Identifier Source: org_study_id

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