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NCT05016518

Comparison of Quality of Recovery (QoR)-15 Scores Between Propofol and Remimazolam Anesthesia

Completed NA Last updated 1 June 2022
What this trial tests

NA trial testing Arm I (Propofol group) in Patients Undergoing Thyroid Surgery for Neoplasm in 140 participants. Completed in 20 May 2022.

Timeline
16 September 2021
Primary endpoint
18 May 2022
20 May 2022

Quick facts

Lead sponsorGangnam Severance Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment140
Start date16 September 2021
Primary completion18 May 2022
Estimated completion20 May 2022
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Gangnam Severance Hospital

Who can join

Adults 20 to 65, female only, with Patients Undergoing Thyroid Surgery for Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Remimazolam is a ultra-short-acting benzodiazepine that is rapidly metabolized in the body by tissue esterase and not accumulates in the body for long periods of infusion. In addition, similar to other benzodiazepines, it is possible to reverse the sedation and anesthetic effects through flumazenil. It has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. The purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between propofol-based and remimazolam-based total intravenous anesthesia in female patients undergoing thyroidectomy. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of the recovery quality between remimazolam and propofol after general anesthesia: systematic review and a meta-analysis of randomized controlled trials.
    Zhu C, Xie R, Qin F, Wang N, et al · · 2024 · cited 2× · PMID 39210920 · DOI 10.7717/peerj.17930

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