Patients Undergoing Thyroid Surgery for Neoplasm
Conditions
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.
Interventions
DRUGArm I (Propofol group)
Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .
DRUGArm II (Remimazolam group)
Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Tracheal extubation time | perioperative - until 48hours | Time from cessation of main anaesthetics to tracheal extubation |
| the incidence of administration of postoperative rescue drug | perioperative - until 72hours | administration of analgesic drug and anti-emetic drug for postoperative management |
| 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. |
| Time to recovery of self respiration | perioperative - until 48hours | Time from cessation of main anaesthetics to recovery of spontaneous breathing |
Countries
South Korea
Outcome results
None listed