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

Primary Purpose

Patients Undergoing Thyroid Surgery for Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (Propofol group)
Arm II (Remimazolam group)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients Undergoing Thyroid Surgery for Neoplasm

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol group

Remimazolam group

Arm Description

Propofol based total intravenous anesthesia

Remimazolam based total intravenous anesthesia

Outcomes

Primary Outcome Measures

postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
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

postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score
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)
Response time
Time from cessation of main anaesthetics to patients' response to verbal command
Tracheal extubation time
Time from cessation of main anaesthetics to tracheal extubation
Time to recovery of self respiration
Time from cessation of main anaesthetics to recovery of spontaneous breathing
PACU(post-anesthesia care unit) stay time
from entry of PACU to go general ward
Postoperative pain score
postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)
Postoperative nausea and vomiting
postoperative nausea and vomiting will be evaluated using 2 point scale (yes, no) at admission to PACU, discharge from PACU, postoperative 6hours
Postoperative sedation score
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".
the incidence of administration of postoperative rescue drug
administration of analgesic drug and anti-emetic drug for postoperative management
hospital stay
days of hospital stay
postoperative complications
postoperative complications

Full Information

First Posted
August 10, 2021
Last Updated
May 30, 2022
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05016518
Brief Title
Comparison of Quality of Recovery (QoR)-15 Scores Between Propofol and Remimazolam Anesthesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Thyroid Surgery for Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Experimental
Arm Description
Propofol based total intravenous anesthesia
Arm Title
Remimazolam group
Arm Type
Active Comparator
Arm Description
Remimazolam based total intravenous anesthesia
Intervention Type
Drug
Intervention Name(s)
Arm I (Propofol group)
Intervention Description
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .
Intervention Type
Drug
Intervention Name(s)
Arm II (Remimazolam group)
Intervention Description
Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.
Primary Outcome Measure Information:
Title
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Description
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)
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score
Description
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)
Time Frame
Postoperative day 2
Title
Response time
Description
Time from cessation of main anaesthetics to patients' response to verbal command
Time Frame
perioperative - until 48hours
Title
Tracheal extubation time
Description
Time from cessation of main anaesthetics to tracheal extubation
Time Frame
perioperative - until 48hours
Title
Time to recovery of self respiration
Description
Time from cessation of main anaesthetics to recovery of spontaneous breathing
Time Frame
perioperative - until 48hours
Title
PACU(post-anesthesia care unit) stay time
Description
from entry of PACU to go general ward
Time Frame
perioperative - until 48hours
Title
Postoperative pain score
Description
postoperative pain score measured by 11-point NRS(numerical rating scale) score (minimum : 0, maximum : 11, the lower the score, the lesser pain)
Time Frame
at admission to PACU, discharge from PACU, postoperative 6hours
Title
Postoperative nausea and vomiting
Description
postoperative nausea and vomiting will be evaluated using 2 point scale (yes, no) at admission to PACU, discharge from PACU, postoperative 6hours
Time Frame
at admission to PACU, discharge from PACU, postoperative 6hours
Title
Postoperative sedation score
Description
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".
Time Frame
at admission to PACU, discharge from PACU
Title
the incidence of administration of postoperative rescue drug
Description
administration of analgesic drug and anti-emetic drug for postoperative management
Time Frame
perioperative - until 72hours
Title
hospital stay
Description
days of hospital stay
Time Frame
preoperative - until discharge (usually 48 hours to 72hours)
Title
postoperative complications
Description
postoperative complications
Time Frame
preoperative - until discharge (usually 48 hours to 72hours)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Song
Organizational Affiliation
GangnamSeverance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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