Comparison of Postoperative QoR-15 Scores Between Sevoflurane and Remimazolam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-26

Study Completion Date

2022-08-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Anterior Cervical Discectomy and Fusion (ACDF) Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1) Sevoflurane group

Sevoflurane based inhalation anesthesia

Group Type EXPERIMENTAL

Sevoflurane based inhalation anesthesia

Intervention Type 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 2) Remimazolam group

Remimazolam based total intravenous anesthesia

Group Type ACTIVE_COMPARATOR

Remimazolam based total intravenous anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes