Clinical trial

Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery: A Prospective Randomized Clinical Trial

Name

FMBSUREC/03032024/Fakhry

Description

The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events.

Trial arms

Trial start

2024-05-01

Estimated PCD

2025-05-01

Trial end

2025-05-01

Status

Recruiting

Phase

Early phase I

Treatment

Dexmedetomidine

Patients will receive dexmedetomidine at a dose of 0.5-1.0 mcg/kg over 5-10 minutes, then a maintenance infusion rate of 0.2-0.5 mcg/kg/min when the bispectral index (BIS) value is between 70 and 80.

Arms:

Dexmedetomidine Group

Propofol

Patients will receive propofol at a dose of 0.25-0.5 mg/kg over 5-10 minutes, then a maintenance Infusion rate of 0.5-2 mg/kg/hr when the bispectral index (BIS) value is between 70 and 80.

Arms:

Propofol Group

Size

420

Primary endpoint

Patient satisfaction

6 hours after the end of surgery.

Eligibility criteria

Inclusion Criteria: * Age between 20-70 years. * Expected time of surgery less than 2 hours Exclusion Criteria: * patients with an initial mini mental state examination (MMSE) score less than 23 * Patients refusing LA * Clotting abnormalities * Impaired mental status * Allergy to any of the study medications * Also, patients were excluded if they had severe cardiac disease, chronic obstructive lung disease, a history of sleep apnea and those who received general anesthesia.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 420, 'type': 'ESTIMATED'}}

Updated at

2024-04-16

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product