Comparison of Recovery Profiles Among Propofol, Remimazolam, and Dexmedetomidine After Intraoperative Sedation

Comparison of Recovery Profiles of Propofol, Dexmedetomidine, and Remimazolam for Monitored Anesthetic Care in Patients Undergoing Upper Limb Surgery Under Brachial Plexus Block : a Randomized Controlled Trial

A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled.

Recruited patients are divided into three groups through computer-generated randomization by using the patient identification number assigned during patient recruitment. (40 people in each group) Standard monitoring is performed when the patient arrives at the operating room. Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial plexus block under ultrasound guidance. After confirming the success of brachial plexus block, administration of propofol, remimazolam, or dexmedetomidine is started according to the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified observer's assessment of alertness/sedation scale) scale. The drug injection ends when the skin suture is started after the main procedure. The time from the end of injection of each drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the recovery room, the Aldrete score is assessed.

The recovery profile, perioperative hemodynamic change, desaturation event, block duration, patient movement during surgery, patient satisfaction, and surgeon's satisfaction were investigated and analyzed for comparison.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Brachial Plexus Block; Orthopedic Procedures; Propofol; Remimazolam; Sedatives
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA PS 1-3
• Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic care

Exclusion Criteria:

• Patients who refuse to participate in this study
• Patients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart disease
• Patients with severe hepatic or renal disease
• Patients who are chronically using antidepressants, anticonvulsants, or psychoactive drugs
• Patients who abuse drugs or alcohol
• Patients with severe sleep apnea
• Patients with cognitive impairment who have severe difficulties in communication
• Patients with allergy to propofol, dexmedetomidine, or remimazolam
• Patients judged to be inappropriate for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remimazolam; Maintenance doses of remimazolam is administered for sedation	Drug: Remimazolam; The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.
Active Comparator: Propofol; Propofol is administered for sedation through target-controlled infusion	Drug: Propofol; Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.
Active Comparator: Dexmedetomidine; Loading and maintenance doses of dexmedetomidine are administered for sedation	Drug: Dexmedetomidine; The patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery profile	Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)	up to 1 hour after post-anesthesia case unit entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in post-anesthesia care unit	Length of stay from entering PACU to leaving	up to 3 hours after post-anesthesia case unit entry
Intraoperative hypotension	mean blood pressure less than 60mmHg	up to 1hour from the initiation of sedative administration
Occurrence of desaturation during surgery	Oxygen saturation less than 92%	From the start of sedative injection to the end of surgery or assessed up to 3 hours
Duration of nerve block		From end of surgery until 24 hours after end of surgery
patient satisfaction	7 point Likert scale	From end of surgery until 24 hours after end of surgery
Surgeon's satisfaction	7 point Likert scale	From end of surgery until 24 hours after end of surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): August 12, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 2021-1591

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No