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

Not Applicable

Completed

• Conditions: Patients Undergoing Thyroid Surgery for Neoplasm
• Interventions: Drug: Arm I (Propofol group); Drug: Arm II (Remimazolam group)

• Registration Number: NCT05016518
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-23
• Study Start: 2021-09-16
• Status Verified: 2022-05
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Arm I (Propofol group)	Propofol based total intravenous anesthesia
Remimazolam group	Arm II (Remimazolam group)	Remimazolam based total intravenous anesthesia

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of