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

NCT05688345 | Completed Phase 4

• 1 other identifier: 2021-1591
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Remimazolam; Propofol; Dexmedetomidine; Orthopedic Procedures; Sedatives; Brachial Plexus Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Length of stay in post-anesthesia care unit

  up to 3 hours after post-anesthesia case unit entry

• Intraoperative hypotension

  up to 1hour from the initiation of sedative administration

• Occurrence of desaturation during surgery

  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

  From end of surgery until 24 hours after end of surgery

Study Arms (3)

Remimazolam

ACTIVE COMPARATOR

Maintenance doses of remimazolam is administered for sedation

Drug: Remimazolam

Propofol

ACTIVE COMPARATOR

Propofol is administered for sedation through target-controlled infusion

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

Loading and maintenance doses of dexmedetomidine are administered for sedation

Drug: Dexmedetomidine

Interventions

Remimazolam DRUG

The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.

Remimazolam

Propofol DRUG

Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.

Propofol

Dexmedetomidine DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Kim HJ, Kim YJ, Lee J, Jeong D, Shin YH, Ro YJ, Kim H, Koh WU. Comparison of the recovery profiles of propofol, dexmedetomidine, and remimazolam for intraoperative sedation in patients undergoing upper limb surgery under brachial plexus blockade: a randomized controlled trial. Can J Anaesth. 2025 Jul;72(7):1090-1100. doi: 10.1007/s12630-025-02987-3. Epub 2025 Jun 13.

  PMID: 40514628 DERIVED

MeSH Terms

Interventions

remimazolam; Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical assistant professor

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 18, 2023
• Study Start: February 23, 2023
• Primary Completion: August 12, 2023
• Study Completion: August 13, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

KR (1)