Clinical trial NCT05016518: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Thyroid Surgery for Neoplasm
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
timeFrame: Postoperative day 1
Secondary outcomes:
measure: postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score
timeFrame: Postoperative day 2
measure: Response time
timeFrame: perioperative - until 48hours
measure: Tracheal extubation time
timeFrame: perioperative - until 48hours
measure: Time to recovery of self respiration
timeFrame: perioperative - until 48hours
measure: PACU(post-anesthesia care unit) stay time
timeFrame: perioperative - until 48hours
measure: Postoperative pain score
timeFrame: at admission to PACU, discharge from PACU, postoperative 6hours
measure: Postoperative nausea and vomiting
timeFrame: at admission to PACU, discharge from PACU, postoperative 6hours
measure: Postoperative sedation score
timeFrame: at admission to PACU, discharge from PACU
measure: the incidence of administration of postoperative rescue drug
timeFrame: perioperative - until 72hours
measure: hospital stay
timeFrame: preoperative - until discharge (usually 48 hours to 72hours)
measure: postoperative complications
timeFrame: preoperative - until discharge (usually 48 hours to 72hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: GangnamSeverance Hospital
name: Young Song
role: PRINCIPAL_INVESTIGATOR
References: