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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05688345
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 10.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Remimazolam; Propofol; Dexmedetomidine; Orthopedic Procedures; Sedatives; Brachial Plexus Block	Drug: Remimazolam; Drug: Propofol; Drug: Dexmedetomidine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jan 25, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Recovery profile [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 Outcome Measures

1. Length of stay in post-anesthesia care unit [up to 3 hours after post-anesthesia case unit entry]

   Length of stay from entering PACU to leaving

2. Intraoperative hypotension [up to 1hour from the initiation of sedative administration]

   mean blood pressure less than 60mmHg

3. Occurrence of desaturation during surgery [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 [From end of surgery until 24 hours after end of surgery]

5. patient satisfaction [From end of surgery until 24 hours after end of surgery]

   7 point Likert scale

6. Surgeon's satisfaction [From end of surgery until 24 hours after end of surgery]

   7 point Likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hajung Kim, clinical assistant professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT05688345
• Other Study ID Numbers: 2021-1591
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine; Propofol

Study Results

No Results Posted as of Jan 18, 2023