Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

NCT04994704 | Completed

• 1 other identifier: 3-2021-0216
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propofol group

EXPERIMENTAL

Propofol based total intravenous anesthesia

Drug: Propfol group

Remimazolam group

ACTIVE COMPARATOR

Remimazolam based total intravenous anesthesia

Drug: Remimazolam group

Interventions

Propfol group DRUG

Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.

Propofol group

Remimazolam group DRUG

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.

Remimazolam group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 6, 2021
• Study Start: December 1, 2021
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

KR (1)