Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05019222

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cervical Discectomy and Fusion (ACDF) Surgery	Drug: Sevoflurane based inhalation anesthesia Drug: Remimazolam based total intravenous anesthesia	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 26, 2021

Anticipated Primary Completion Date :

Aug 25, 2022

Anticipated Study Completion Date :

Aug 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1) Sevoflurane group Sevoflurane based inhalation anesthesia	Drug: Sevoflurane based inhalation anesthesia 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.
Active Comparator: Arm 2) Remimazolam group Remimazolam based total intravenous anesthesia	Drug: Remimazolam based total intravenous anesthesia 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

Intervention/Treatment

Experimental: Arm 1) Sevoflurane group

Sevoflurane based inhalation anesthesia

Drug: Sevoflurane based inhalation anesthesia

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.

Active Comparator: Arm 2) Remimazolam group

Remimazolam based total intravenous anesthesia

Drug: Remimazolam based total intravenous anesthesia

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.

Outcome Measures

Primary Outcome Measures

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

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
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