Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Dexmedetomidine; Cataract Surgery; Peribulbar
• Intervention / Treatment: Drug: Topical dexmedetomidine; Drug: Reginal dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mohammed F Algyar, MD; Phone Number: 047 00201111645345; Email: mohammad.algaiar@med.kfs.edu.eg

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Recruiting
      • Mohammed Fouad Mohamed Algyar
      • Contact: Mohammed F Algyar, MD; Phone Number: 047 00201111645345; Email: mohammad.algaiar@med.kfs.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical dexmedetomidine group; Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic	Drug: Topical dexmedetomidine; Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic
Active Comparator: Reginal dexmedetomidine group; Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia-related complications	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.	2 hours postoperatively
Sedation level	Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.	2 hours postoperatively
pain during and after the surgery	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.	2 hours postoperatively
Need for additional anesthesia during surgery and surgeon	The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded	During surgery
Intraoperative difficulties	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	2 hours postoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Mohammed F Algyar, MD, Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): October 15, 2023
• Study Completion (Estimated): October 15, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: MKSU 50-11-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available under a reasonable request from the corresponding author
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No