Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Not Applicable

Completed

• Conditions: Patients Undergoing Spine Surgery
• Interventions: Drug: Remimazolam group; Drug: Propfol group

• Registration Number: NCT04994704
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-06
• Study Start: 2021-12-01
• Status Verified: 2023-07
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Adult patients who aged 20-70 years with ASA-PS 1-3,
• diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy
• intraoperative neurophysiological monitoring.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam group	Remimazolam group	Remimazolam based total intravenous anesthesia
Propofol group	Propfol group	Propofol based total intravenous anesthesia

Primary Outcome Measures

Name	Time	Method
The difference of QoR-15 scores between two groups (propofol vs. remimazolam)	postoperative day 1	The difference of scores in the Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores means better.

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of