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Clinical Trials/NCT04983966
NCT04983966
Completed
Not Applicable

Comparison of Quality of Recovery (QoR)-15 Scores According to the Anesthetics (Desflurane vs. Remimazolam) in the Patients With Lumbar Fusion Surgery: a Prospective Double-blind Randomized Controlled Trial

Gangnam Severance Hospital1 site in 1 country76 target enrollmentAugust 4, 2021

Overview

Phase
Not Applicable
Intervention
Desflurane
Conditions
Lumbar Fusion Surgery
Sponsor
Gangnam Severance Hospital
Enrollment
76
Locations
1
Primary Endpoint
The difference of QoR-15 scores
Status
Completed
Last Updated
2 years ago

Overview

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 lumbar fusion 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 our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.

Registry
clinicaltrials.gov
Start Date
August 4, 2021
End Date
February 14, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Myoung Hwa Kim

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients who aged 20-70 years with ASA-PS 1-3, BMI \<30 undergoing lumbar fusion surgery under general anesthesia

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

Arms & Interventions

Desflurane group

General anesthesia with volatile agent of desflurane

Intervention: Desflurane

Remimazolam group

Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.

Intervention: Remimazolam

Outcomes

Primary Outcomes

The difference of QoR-15 scores

Time Frame: postoperative day 1

The difference of scores in the Quality of Recovery (QoR)-15 survey between desflurane group and remimazolam group. 0 (minimum), 150 (maximum): Higher scores means better.

Study Sites (1)

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