NCT03735368

Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Abd-Elazeem Abd-Elhameed Elbakry · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.

Detailed description

The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine Injection	Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
DRUG	Placebo oral capsule	placebo oral capsules
DRUG	Pregabalin Oral Capsule	150 mg pregabalin Oral Capsule
DRUG	topical anesthesia	topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Timeline

• Start date: 2018-12-10
• Primary completion: 2019-10-30
• Completion: 2019-11-29
• First posted: 2018-11-08
• Last updated: 2019-12-27

Locations

1 site across 1 country: Egypt