Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Spine Surgery
• Intervention / Treatment: Drug: Propfol group; Drug: Remimazolam group

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Woo Han; Phone Number: 82-2-2019-2740; Email: HANESTH@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeverance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol group; Propofol based total intravenous anesthesia	Drug: Propfol group; Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.
Active Comparator: Remimazolam group; Remimazolam based total intravenous anesthesia	Drug: Remimazolam group; Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 3-2021-0216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No