Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Phase 2

Recruiting

• Conditions: Dexmedetomidine; Cataract Surgery; Peribulbar; Anesthesia
• Interventions: Drug: Topical dexmedetomidine; Drug: Reginal dexmedetomidine

• Registration Number: NCT05692167
• Lead Sponsor: Kafrelsheikh University

Brief Summary

The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery

Detailed Description

Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.

Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.

Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-07-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery

Exclusion Criteria

• Patients who are younger than 18 years
• The usual contraindications for regional anesthesia such as patients refusing LA
• Clotting abnormalities
• Impaired mental status
• Allergy to any of the study medications
• patients had the severe cardiac disease
• chronic obstructive lung disease and a history of sleep apnea
• contraindications to the use of dexmedetomidine
• history or significant cardiovascular disease risk factors
• significant coronary artery disease or any known genetic predisposition
• history of any kind of drug allergy
• drug abuse
• psychological or other emotional problems
• special diet or lifestyle
• clinically significant abnormal findings in physical examination
• electrocardiographic (ECG) or laboratory screening
• known systemic disease requiring the use of anticoagulants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical dexmedetomidine group	Topical dexmedetomidine	Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic
Reginal dexmedetomidine group	Reginal dexmedetomidine	Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Primary Outcome Measures

Name	Time	Method
Inadvertent eye movement	2 hours postoperatively	Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.

Secondary Outcome Measures

Name	Time	Method
Anesthesia-related complications	2 hours postoperatively	The patients will be asked whether the cataract surgery was more or less painful than having the needle used for intravenous infusions inserted into the back of the hand.
Sedation level	2 hours postoperatively	Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.
pain during and after the surgery	2 hours postoperatively	Immediately after surgery, patients will be asked to grade the pain felt during the operation, including the pain felt after delivery of topical or peribulbar anaesthesia.
Need for additional anesthesia during surgery and surgeon	During surgery	The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded
Intraoperative difficulties	2 hours postoperatively	The surgeon will also be requested to grade any difficulties encountered during surgery immediately after the operation, using a 4-point scale, where 1 = no difficulty and 4 = extremely difficult

Trial Locations

Locations (1)

Mohammed Fouad Mohamed Algyar; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt