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Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04994704
Enrollment
73
Registered
2021-08-06
Start date
2021-12-01
Completion date
2023-07-12
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Spine Surgery

Brief summary

Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.

Interventions

DRUGPropfol group

Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.

Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.

Sponsors

Gangnam Severance Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult patients who aged 20-70 years with ASA-PS 1-3, * diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy * intraoperative neurophysiological monitoring.

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

Design outcomes

Primary

MeasureTime frameDescription
The difference of QoR-15 scores between two groups (propofol vs. remimazolam)postoperative day 1The difference of scores in the Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores means better.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026