Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692167
• Other study ID #: MKSU 50-11-3
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2023
• Source: Kafrelsheikh University
• Contact: Mohammed F Algyar, MD
• Phone: 00201111645345
• Email: mohammad.algaiar[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cataract
• Cataract Surgery
• Dexmedetomidine

Intervention

Drug:
• Topical dexmedetomidine
Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic
• 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

Locations

Country	Name	City	State
Egypt	Mohammed Fouad Mohamed Algyar	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Sedation level	Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.	2 hours postoperatively
Secondary	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
Secondary	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
Secondary	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