Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

NCT ID: NCT04994704

Last Updated: 2023-07-20

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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Patients Undergoing Spine 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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Propofol group

Propofol based total intravenous anesthesia

Group Type EXPERIMENTAL

Propfol group

Intervention Type DRUG

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

Remimazolam group

Remimazolam based total intravenous anesthesia

Group Type ACTIVE_COMPARATOR

Remimazolam group

Intervention Type DRUG

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.

Interventions

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Propfol group

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

Intervention Type DRUG

Remimazolam group

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Woo Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2021-0216

Identifier Type: -

Identifier Source: org_study_id

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