Comparison of Recovery Profile After TIVA Between Remimazolam With Flumazenil and Propofol

Seoul National University

Status: Completed

Conditions: Anesthesia, Intravenous

Treatments: Drug: remimazolam-based TIVA; Drug: propofol-based TIVA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05047939

H-2105-016-1217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

remimazolam group

Experimental group

Description:

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 0.2mg, is administered at the end of surgery. In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.

Treatment:

Drug: remimazolam-based TIVA

propofol group

Active Comparator group

Description:

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). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.

Treatment:

Drug: propofol-based TIVA