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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients Undergoing Thyroid Surgery for Neoplasm

Intervention / Treatment
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* Drug: Arm I (Propofol group)
* Drug: Arm II (Remimazolam group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol group<br>Propofol based total intravenous anesthesia | Drug: Arm I (Propofol group)<br>* Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .<br>|
| Active Comparator: Remimazolam group<br>Remimazolam based total intravenous anesthesia | Drug: Arm II (Remimazolam group)<br>* Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| PACU(post-anesthesia care unit) stay time | from entry of PACU to go general ward | 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 | 
| 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 complications | postoperative complications | preoperative - until discharge (usually 48 hours to 72hours) |