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Comparison of Postoperative QoR-15 Scores Between Propofol and Remimazolam

Y

Yonsei University Health System (YUHS)

Status

Completed

Conditions

Patients Undergoing Spine Surgery

Treatments

Drug: Propfol group
Drug: Remimazolam group

Study type

Interventional

Funder types

Other

Identifiers

NCT04994704
3-2021-0216

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

73 participants in 2 patient groups

Propofol group
Experimental group
Description:
Propofol based total intravenous anesthesia
Treatment:
Drug: Propfol group
Remimazolam group
Active Comparator group
Description:
Remimazolam based total intravenous anesthesia
Treatment:
Drug: Remimazolam group

Trial contacts and locations

1

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Central trial contact

Dong Woo Han

Data sourced from clinicaltrials.gov

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