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

Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During Total Intravenous Anesthesia in Female Patients Undergoing Thyroid Surgery

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Thyroid Surgery for Neoplasm
• Intervention / Treatment: Drug: Arm I (Propofol group); Drug: Arm II (Remimazolam group)

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU(post-anesthesia care unit) stay time	from entry of PACU to go general ward	perioperative - until 48hours
the incidence of administration of postoperative rescue drug	administration of analgesic drug and anti-emetic drug for postoperative management	perioperative - until 72hours
hospital stay	days of hospital stay	preoperative - until discharge (usually 48 hours to 72hours)
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)	Postoperative day 2
Response time	Time from cessation of main anaesthetics to patients' response to verbal command	perioperative - until 48hours
Tracheal extubation time	Time from cessation of main anaesthetics to tracheal extubation	perioperative - until 48hours
Time to recovery of self respiration	Time from cessation of main anaesthetics to recovery of spontaneous breathing	perioperative - until 48hours
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)	at admission to PACU, discharge from PACU, postoperative 6hours
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	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".	at admission to PACU, discharge from PACU
postoperative complications	postoperative complications	preoperative - until discharge (usually 48 hours to 72hours)

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Young Song, GangnamSeverance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Actual): May 18, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2021-0424-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No