Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2019-11-29

Brief Summary

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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.

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Detailed Description

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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

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Conscious Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The patients, the surgeons and the research team will be blinded to the randomization.

Study Groups

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Control

placebo oral capsule+ dexmedetomidine+topical anesthesia

Group Type PLACEBO_COMPARATOR

Dexmedetomidine Injection

Intervention Type DRUG

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

Placebo oral capsule

Intervention Type DRUG

placebo oral capsules

topical anesthesia

Intervention Type DRUG

topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Dexmedetomidine- Pregabalin

Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Injection

Intervention Type DRUG

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

Pregabalin Oral Capsule

Intervention Type DRUG

150 mg pregabalin Oral Capsule

topical anesthesia

Intervention Type DRUG

topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Interventions

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Dexmedetomidine Injection

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

Intervention Type DRUG

Placebo oral capsule

placebo oral capsules

Intervention Type DRUG

Pregabalin Oral Capsule

150 mg pregabalin Oral Capsule

Intervention Type DRUG

topical anesthesia

topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine placebo pregabalin Benoxinate Hydrochloride 0.4% Eye Drops

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No