Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

Not Applicable

Completed

• Conditions: Anterior Cervical Discectomy and Fusion (ACDF) Surgery
• Interventions: Drug: Sevoflurane based inhalation anesthesia; Drug: Remimazolam based total intravenous anesthesia

• Registration Number: NCT05019222
• 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 cervical spine 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 the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-24
• Study Start: 2021-09-26
• Primary Completion: 2022-08-14
• Study Completion: 2022-08-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Adult patients who aged 20-70 years
• ASA-PS: 1-3
• BMI < 30
• Anterior cervical discectomy and fusion surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1) Sevoflurane group	Sevoflurane based inhalation anesthesia	Sevoflurane based inhalation anesthesia
Arm 2) Remimazolam group	Remimazolam based total intravenous anesthesia	Remimazolam based total intravenous anesthesia

Primary Outcome Measures

Name	Time	Method
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores	postoperative day 1	The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better.

Trial Locations

Locations (1)

Myung Hwa Kim; 🇰🇷 Seoul, Korea, Republic of