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

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.

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Key information

Conditions

Lumbar Fusion Surgery

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients who aged 20-70 years with ASA-PS 1-3, BMI <30 undergoing lumbar fusion surgery under general anesthesia

Exclusion criteria

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

Treatment and study plan

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

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

Primary outcomes

The difference of QoR-15 scores

Time frame: postoperative day 1

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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Comparison of Quality of Recovery (QoR)-15 Scores According to the Anesthetics (Desflurane vs. Remimazolam) in the Patients With Lumbar Fusion Surgery: a Prospective Double-blind Randomized Controlled Trial

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jul 30, 2021
Registry last updated: Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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