Clinical trial NCT05688345: Comparison of Recovery Profiles Among Propofol, Remimazolam, and Dexmedetomidine After Intraoperative Sedation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Remimazolam
Propofol
Dexmedetomidine
Orthopedic Procedures
Sedatives
Brachial Plexus Block
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recovery profile
timeFrame: up to 1 hour after post-anesthesia case unit entry
Secondary outcomes:
measure: Length of stay in post-anesthesia care unit
timeFrame: up to 3 hours after post-anesthesia case unit entry
measure: Intraoperative hypotension
timeFrame: up to 1hour from the initiation of sedative administration
measure: Occurrence of desaturation during surgery
timeFrame: From the start of sedative injection to the end of surgery or assessed up to 3 hours
measure: Duration of nerve block
timeFrame: From end of surgery until 24 hours after end of surgery
measure: patient satisfaction
timeFrame: From end of surgery until 24 hours after end of surgery
measure: Surgeon's satisfaction
timeFrame: From end of surgery until 24 hours after end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: