Clinical trial NCT05047939: Comparison of Recovery Profile After TIVA Between Remimazolam With Flumazenil and Propofol
Official title: Comparison of Recovery Profile After Total Intravenous Anesthesia Between Remimazolam With Flumazenil and Propofol in Patients Undergoing Thyroidectomy: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Intravenous
Keywords: Anesthetics
Anesthetics, General
Benzodiazepines
Flumazenil
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hana Pharm Co., Ltd.
First posted: 2021-09-17
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized single-blinded study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in eye opening time between the two groups
timeFrame: Up to the first eye opening from stopping injection of anesthetics
Secondary outcomes:
measure: Difference in extubation time between the two groups
timeFrame: Up to extubation from stopping injection of anesthetics
measure: Modified Aldrete score
timeFrame: Within 5 minutes of arrival at the post-anesthetic care unit
measure: length of post-anesthetic care unit stay
timeFrame: immediately after discharge from the post-anesthetic care unit
measure: Postoperative nausea and vomiting during the first 24 hours postoperatively
timeFrame: during the first 24 hours postoperatively
measure: postoperative quality of recovery
timeFrame: at 24 hours postoperatively
measure: Intraoperative hemodynamic stability
timeFrame: during the operation
measure: Intraoperative anesthetic depth stability
timeFrame: during the operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Wesolowski AM, Zaccagnino MP, Malapero RJ, Kaye AD, Urman RD. Remimazolam: Pharmacologic Considerations and Clinical Role in Anesthesiology. Pharmacotherapy. 2016 Sep;36(9):1021-7. doi: 10.1002/phar.1806. Epub 2016 Sep 1.