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

Sponsor
Gangnam Severance Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05016518
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
8.1
Actual Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Arm I (Propofol group)
  • Drug: Arm II (Remimazolam group)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During Total Intravenous Anesthesia in Female Patients Undergoing Thyroid Surgery
Actual Study Start Date :
Sep 16, 2021
Actual Primary Completion Date :
May 18, 2022
Actual Study Completion Date :
May 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Propofol group

Propofol based total intravenous anesthesia

Drug: Arm I (Propofol group)
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .
Active Comparator: Remimazolam group

Remimazolam based total intravenous anesthesia

Drug: Arm II (Remimazolam group)
Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.

Outcome Measures

Primary Outcome Measures

  1. postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score [Postoperative day 1]

    Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)

Secondary Outcome Measures

  1. postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score [Postoperative day 2]

    Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2(minimum value : 0, maximum value : 150, the higher the score, the better the result)

  2. Response time [perioperative - until 48hours]

    Time from cessation of main anaesthetics to patients' response to verbal command

  3. Tracheal extubation time [perioperative - until 48hours]

    Time from cessation of main anaesthetics to tracheal extubation

  4. Time to recovery of self respiration [perioperative - until 48hours]

    Time from cessation of main anaesthetics to recovery of spontaneous breathing

  5. PACU(post-anesthesia care unit) stay time [perioperative - until 48hours]

    from entry of PACU to go general ward

  6. Postoperative pain score [at admission to PACU, discharge from PACU, postoperative 6hours]

    postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)

  7. Postoperative nausea and vomiting [at admission to PACU, discharge from PACU, postoperative 6hours]

    postoperative nausea and vomiting will be evaluated using 2 point scale (yes, no) at admission to PACU, discharge from PACU, postoperative 6hours

  8. Postoperative sedation score [at admission to PACU, discharge from PACU]

    monitored through the sedation scale called Richmond Agitation-Sedation Scale(RASS). RASS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from +4 "combative" to -5 "unarousable".

  9. the incidence of administration of postoperative rescue drug [perioperative - until 72hours]

    administration of analgesic drug and anti-emetic drug for postoperative management

  10. hospital stay [preoperative - until discharge (usually 48 hours to 72hours)]

    days of hospital stay

  11. postoperative complications [preoperative - until discharge (usually 48 hours to 72hours)]

    postoperative complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

•20≤Age≤65 female Open thyroidectomy ASA-PS I-III

Exclusion Criteria:

  • Allergic history of any study drug

  • Taking any sedative, opioid, or sleep aid drugs

  • Psychiatric or neurological disorder

  • BMI>30 kg/m2

  • Pregnancy

  • Vulnerable patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gangnam Severance Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Gangnam Severance Hospital

Investigators

  • Principal Investigator: Young Song, GangnamSeverance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young Song, Associate professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier:
NCT05016518
Other Study ID Numbers:
  • 2021-0424-002
First Posted:
Aug 23, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thyroid Diseases
Propofol

Study Results

No Results Posted as of Jun 1, 2022