Anesthesia, Intravenous
Conditions
Keywords
Anesthetics, Anesthetics, General, Benzodiazepines, Flumazenil
Brief summary
This prospective, randomized, single-blinded study is designed to compare the recovery profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized by flumazenil can significantly shorten the time from the end of anesthetic administration to eye-opening compared to propofol-based TIVA.
Detailed description
Adult patients undergoing elective thyroidectomy are randomly allocated to receive propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including the time from the end of anesthetic administration to eye-opening, the time from the end of anesthetic administration to extubation, hemodynamic stability, stability of anesthetic depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using the quality of recovery-15 was assessed by an investigator. The primary outcome is the time from the end of anesthetic administration to eye-opening.
Interventions
DRUGremimazolam-based TIVA
In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery.
DRUGpropofol-based TIVA
In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France).
Sponsors
Hana Pharm Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will receive general anesthesia, therefore they cannot know their anesthetic agents. Physicians involved in this study will investigate the outcomes.
Intervention model description
A prospective randomized single-blinded study
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo elective thyroidectomy under general anesthesia * American Society of Anesthesiologists (ASA)physical classification I-II * Willingness and ability to sign an informed consent document
Exclusion criteria
* American Society of Anesthesiologists (ASA)physical classification III or more * BMI \> 40kg/m\^2 * Allergies to anesthetic or analgesic medications (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, sugammadex, flumazenil) * Patients who receive mechanical ventilation morethan 2 hours after surgery * Patients who receive the following medications within 24 hours prior to general anesthetics: anxiolytics, antipsychotics, rifampicin, succinycholine, neostigmine, flumazenil, cyclosporin * Patients with galactose intolerance or Lapp Lactase deficiency or glucose-galactose malabsorption * Medical or psychological disease that can affect the treatment response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in eye opening time between the two groups | Up to the first eye opening from stopping injection of anesthetics | difference in eye opening time after stopping injection of anesthetics (From the end of anesthetic administration to the first eye opening) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Aldrete score | Within 5 minutes of arrival at the post-anesthetic care unit | Modified Aldrete score (0-10, higher scores mean a better outcome) measured when admit the post-anesthetic care unit |
| length of post-anesthetic care unit stay | immediately after discharge from the post-anesthetic care unit | length of post-anesthetic care unit stay (minute) |
| Postoperative nausea and vomiting during the first 24 hours postoperatively | during the first 24 hours postoperatively | Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively |
| Difference in extubation time between the two groups | Up to extubation from stopping injection of anesthetics | difference in extubation time after stopping injection of anesthetics (From the end of anesthetic administration to extubation) |
| Intraoperative hemodynamic stability | during the operation | Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) |
| Intraoperative anesthetic depth stability | during the operation | Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%) |
| postoperative quality of recovery | at 24 hours postoperatively | quality of recovery measured by the Korean version of the Quality of Recovery-15 (QoR-15K, 0-150, higher scores mean a better outcome) |
Countries
South Korea
Outcome results
None listed