Comparison of Postoperative QoR-15 Scores Between Desflurane and Remimazolam in Lumbar Fusion Surgery

Not Applicable

Completed

• Conditions: Lumbar Fusion Surgery
• Interventions: Drug: Desflurane; Drug: Remimazolam

• Registration Number: NCT04983966
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the lumbar fusion surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-07-30
• Study Start: 2021-08-04
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Adult patients who aged 20-70 years with ASA-PS 1-3, BMI <30 undergoing lumbar fusion surgery under general anesthesia

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Exclusion Criteria

• Tolerance or hypersensitivity to benzodiazepine or propofol
• Dependence or addiction to psychotropic drugs or alcohol
• Pregnant women
• subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane group	Desflurane	General anesthesia with volatile agent of desflurane
Remimazolam group	Remimazolam	Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.

Primary Outcome Measures

Name	Time	Method
The difference of QoR-15 scores	postoperative day 1	The difference of scores in the Quality of Recovery (QoR)-15 survey between desflurane group and remimazolam group. 0 (minimum), 150 (maximum): Higher scores means better.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of