Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Abd-Elazeem Abd-Elhameed Elbakry

Status and phase: Completed; Phase 2

Conditions: Conscious Sedation

Treatments: Drug: Dexmedetomidine Injection; Drug: Placebo oral capsule; Drug: Pregabalin Oral Capsule; Drug: topical anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03735368

2018/10/15/5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

placebo oral capsule+ dexmedetomidine+topical anesthesia

Treatment:

Drug: topical anesthesia

Drug: Placebo oral capsule

Drug: Dexmedetomidine Injection

Dexmedetomidine- Pregabalin

Active Comparator group

Description:

Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia

Treatment:

Drug: topical anesthesia

Drug: Pregabalin Oral Capsule

Drug: Dexmedetomidine Injection