Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

NCT05019222 | Completed

• 1 other identifier: 3-2021- 0257
• Study Type: interventional
• Target: 72
• 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 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.

Conditions

Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Keywords

Cervical surgery; Quality of Recovery; Remimazolam; sevoflurane

Outcome Measures

Primary Outcomes (1)

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

  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.

  postoperative day 1

Study Arms (2)

Arm 1) Sevoflurane group

EXPERIMENTAL

Sevoflurane based inhalation anesthesia

Drug: Sevoflurane based inhalation anesthesia

Arm 2) Remimazolam group

ACTIVE COMPARATOR

Remimazolam based total intravenous anesthesia

Drug: Remimazolam based total intravenous anesthesia

Interventions

Sevoflurane based inhalation anesthesia DRUG

Sevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia.

Arm 1) Sevoflurane group

Remimazolam based total intravenous anesthesia DRUG

Remimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia.

Arm 2) 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
• ASA-PS: 1-3
• BMI \< 30
• Anterior cervical discectomy and fusion surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Myung Hwa Kim

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: Associate Professor

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: September 26, 2021
• Primary Completion: August 14, 2022
• Study Completion: August 14, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)