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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
58
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.
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).
Seoul National University Hospital
Seoul, South Korea
Difference in eye opening time between the two groups
difference in eye opening time after stopping injection of anesthetics (From the end of anesthetic administration to the first eye opening)
Time frame: Up to the first eye opening from stopping injection of anesthetics
Difference in extubation time between the two groups
difference in extubation time after stopping injection of anesthetics (From the end of anesthetic administration to extubation)
Time frame: Up to extubation from stopping injection of anesthetics
Modified Aldrete score
Modified Aldrete score (0-10, higher scores mean a better outcome) measured when admit the post-anesthetic care unit
Time frame: Within 5 minutes of arrival at the post-anesthetic care unit
length of post-anesthetic care unit stay
length of post-anesthetic care unit stay (minute)
Time frame: immediately after discharge from the post-anesthetic care unit
Postoperative nausea and vomiting during the first 24 hours postoperatively
Incidence of postoperative nausea and vomiting during the first 24 hours postoperatively
Time frame: during the first 24 hours postoperatively
postoperative quality of recovery
quality of recovery measured by the Korean version of the Quality of Recovery-15 (QoR-15K, 0-150, higher scores mean a better outcome)
Time frame: at 24 hours postoperatively
Intraoperative hemodynamic stability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Intraoperative hemodynamic measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)
Time frame: during the operation
Intraoperative anesthetic depth stability
Intraoperative anesthetic depth stability measured by performance error (%), median performance error (%), median absolute performance error (%), and wobble (%)
Time frame: during the operation