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Completed

NCT Number: NCT05016518

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

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.

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Key information

Conditions

Patients Undergoing Thyroid Surgery for Neoplasm

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm I (Propofol group)

Drug

Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil .

Arm II (Remimazolam group)

Drug

Remimazolam group will be started and maintained total intravenous anesthesia with remimazolam and remifentanil.

Primary outcomes

  1. postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score

    Time frame: 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 outcomes

  1. postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score

    Time frame: 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)

  2. Response time

    Time frame: perioperative - until 48hours

    Time from cessation of main anaesthetics to patients' response to verbal command

  3. Tracheal extubation time

    Time frame: perioperative - until 48hours

    Time from cessation of main anaesthetics to tracheal extubation

  4. Time to recovery of self respiration

    Time frame: perioperative - until 48hours

    Time from cessation of main anaesthetics to recovery of spontaneous breathing

  5. PACU(post-anesthesia care unit) stay time

    Time frame: perioperative - until 48hours

    from entry of PACU to go general ward

  6. Postoperative pain score

    Time frame: 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)

  7. Postoperative nausea and vomiting

    Time frame: 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

  8. Postoperative sedation score

    Time frame: 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".

  9. the incidence of administration of postoperative rescue drug

    Time frame: perioperative - until 72hours

    administration of analgesic drug and anti-emetic drug for postoperative management

  10. hospital stay

    Time frame: preoperative - until discharge (usually 48 hours to 72hours)

    days of hospital stay

  11. postoperative complications

    Time frame: preoperative - until discharge (usually 48 hours to 72hours)

    postoperative complications

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2021
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.