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

Dexmedetomidine Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05688345
• Other study ID #: 2021-1591
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2023
• Est. completion date: August 13, 2023

Study information

• Verified date: January 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 13, 2023
• Est. primary completion date: August 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Remimazolam
The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.
• Propofol
Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intraoperative hypotension	mean blood pressure less than 60mmHg	up to 1hour from the initiation of sedative administration
Secondary	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
Secondary	Duration of nerve block		From end of surgery until 24 hours after end of surgery
Secondary	patient satisfaction	7 point Likert scale	From end of surgery until 24 hours after end of surgery
Secondary	Surgeon's satisfaction	7 point Likert scale	From end of surgery until 24 hours after end of surgery