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Completed

NCT Number: NCT05320016

Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

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.

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Key information

Conditions

Day Surgery Patient Outcome Assessment Quality of Recovery Remimazolam

Age range

19 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

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

Primary outcomes

  1. Quality of recovery

    Time frame: 24 hours after ambulatory hysteroscopic surgery

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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