Comparison of Postoperative QoR-15 Scores Between Desflurane and Remimazolam in Lumbar Fusion Surgery

NCT04983966 | Completed DMC

• 1 other identifier: 3-2021-0214
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Fusion Surgery

Outcome Measures

Primary Outcomes (1)

• The difference of QoR-15 scores

  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.

  postoperative day 1

Study Arms (2)

Desflurane group

EXPERIMENTAL

General anesthesia with volatile agent of desflurane

Drug: Desflurane

Remimazolam group

ACTIVE COMPARATOR

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.

Drug: Remimazolam

Interventions

Desflurane DRUG

General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion. 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

Desflurane group

Remimazolam DRUG

General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion. 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

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, BMI \<30 undergoing lumbar fusion surgery under general anesthesia

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

MeSH Terms

Interventions

remimazolam

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: Associate Professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: July 30, 2021
• Study Start: August 4, 2021
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

KR (1)