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Clinical Trials/NCT05019222
NCT05019222
Completed
Not Applicable

Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam

Gangnam Severance Hospital1 site in 1 country72 target enrollmentSeptember 26, 2021

Overview

Phase
Not Applicable
Intervention
Sevoflurane based inhalation anesthesia
Conditions
Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Sponsor
Gangnam Severance Hospital
Enrollment
72
Locations
1
Primary Endpoint
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores
Status
Completed
Last Updated
3 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 cervical spine 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 the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.

Registry
clinicaltrials.gov
Start Date
September 26, 2021
End Date
August 14, 2022
Last Updated
3 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
  • ASA-PS: 1-3
  • BMI \< 30
  • Anterior cervical discectomy and fusion surgery

Exclusion Criteria

  • Tolerance or hypersensitivity to benzodiazepine
  • 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

Arm 1) Sevoflurane group

Sevoflurane based inhalation anesthesia

Intervention: Sevoflurane based inhalation anesthesia

Arm 2) Remimazolam group

Remimazolam based total intravenous anesthesia

Intervention: Remimazolam based total intravenous anesthesia

Outcomes

Primary Outcomes

The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores

Time Frame: postoperative day 1

The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better.

Study Sites (1)

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