Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Abd-Elazeem Abd-Elhameed Elbakry60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Conscious Sedation

Interventions

Dexmedetomidine InjectionDRUG

Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion

Placebo oral capsuleDRUG

placebo oral capsules

Pregabalin Oral CapsuleDRUG

150 mg pregabalin Oral Capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society Of Anesthesiologists (ASA) I and II physical status. * Scheduled for cataract extraction under topical anesthesia. Exclusion Criteria: * Hepatic or renal impairment. * Taking chronic psychotropic medications. * Mental instability. * Morbid obesity. * Alcohol abuse. * Substance abuse. * Pregnant and lactating females. * History of allergy to the study drugs used

Locations (1)

Faculty of Medicine

Cairo, Shebin El-kom, Egypt

Outcomes

Primary Outcomes

sedation score changes

Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.