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Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04994704
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Propfol group
  • Drug: Remimazolam group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Aug 5, 2021
Anticipated Primary Completion Date :
Aug 4, 2022
Anticipated Study Completion Date :
Aug 4, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GangnamSeverance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dong Woo Han, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT04994704
Other Study ID Numbers:
  • 3-2021-0216
First Posted:
Aug 6, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 12, 2021