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Completed

NCT Number: NCT05688345

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

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.

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Key information

Conditions

Remimazolam Brachial Plexus Block Dexmedetomidine Orthopedic Procedures Propofol Sedatives

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

Propofol

Drug

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

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.

Primary outcomes

  1. Recovery profile

    Time frame: up to 1 hour after post-anesthesia case unit entry

    Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

Secondary outcomes

  1. Length of stay in post-anesthesia care unit

    Time frame: up to 3 hours after post-anesthesia case unit entry

    Length of stay from entering PACU to leaving

  2. Intraoperative hypotension

    Time frame: up to 1hour from the initiation of sedative administration

    mean blood pressure less than 60mmHg

  3. Occurrence of desaturation during surgery

    Time frame: From the start of sedative injection to the end of surgery or assessed up to 3 hours

    Oxygen saturation less than 92%

  4. Duration of nerve block

    Time frame: From end of surgery until 24 hours after end of surgery

  5. patient satisfaction

    Time frame: From end of surgery until 24 hours after end of surgery

    7 point Likert scale

  6. Surgeon's satisfaction

    Time frame: From end of surgery until 24 hours after end of surgery

    7 point Likert scale

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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