Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

NCT05692167 | Unknown Phase 2

• 1 other identifier: MKSU 50-11-3
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dexmedetomidine; Cataract Surgery; Peribulbar; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anesthesia-related complications

  2 hours postoperatively

• Sedation level

  2 hours postoperatively

• pain during and after the surgery

  2 hours postoperatively

• Need for additional anesthesia during surgery and surgeon

  During surgery

• Intraoperative difficulties

  2 hours postoperatively

Study Arms (2)

Topical dexmedetomidine group

ACTIVE COMPARATOR

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Drug: Topical dexmedetomidine

Reginal dexmedetomidine group

ACTIVE COMPARATOR

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

Interventions

Topical dexmedetomidine DRUG

Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic

Topical dexmedetomidine group

Reginal dexmedetomidine DRUG

Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block

Reginal dexmedetomidine group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Mohammed Fouad Mohamed Algyar

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohammed F Algyar, MD

  Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed F Algyar, MD

CONTACT

00201111645345; mohammad.algaiar@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: July 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after the end of the study

Locations

EG (1)