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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .
Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.
Gangnam Severance Hospital
Seoul, South Korea
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)
Time frame: Postoperative day 1
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)
Time frame: Postoperative day 2
Response time
Time from cessation of main anaesthetics to patients' response to verbal command
Time frame: perioperative - until 48hours
Tracheal extubation time
Time from cessation of main anaesthetics to tracheal extubation
Time frame: perioperative - until 48hours
Time to recovery of self respiration
Time from cessation of main anaesthetics to recovery of spontaneous breathing
Time frame: perioperative - until 48hours
PACU(post-anesthesia care unit) stay time
from entry of PACU to go general ward
Time frame: 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)
Time frame: 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
Time frame: 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".
Time frame: 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
Time frame: perioperative - until 72hours
hospital stay
days of hospital stay
Time frame: preoperative - until discharge (usually 48 hours to 72hours)
postoperative complications
postoperative complications
Time frame: preoperative - until discharge (usually 48 hours to 72hours)
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