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Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Primary Purpose

Dexmedetomidine, Cataract Surgery, Peribulbar

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Topical dexmedetomidine

Reginal dexmedetomidine

About this trial

This is an interventional treatment trial for Dexmedetomidine

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mohammed Fouad Mohamed AlgyarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Topical dexmedetomidine group

Reginal dexmedetomidine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Inadvertent eye movement

Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.

Secondary Outcome Measures

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.

Sedation level

Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.

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.

Need for additional anesthesia during surgery and surgeon

The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded

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

Full Information

NCT ID

NCT05692167

First Posted

January 11, 2023

Last Updated

September 3, 2023

Sponsor

Kafrelsheikh University

1. Study Identification

Unique Protocol Identification Number

NCT05692167

Brief Title

Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2023 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dexmedetomidine, Cataract Surgery, Peribulbar, Anesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Topical dexmedetomidine group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Reginal dexmedetomidine group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Topical dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Reginal dexmedetomidine

Intervention Description

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 Measure Information:

Title

Inadvertent eye movement

Description

Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.

Time Frame

2 hours postoperatively

Secondary Outcome Measure Information:

Title

Anesthesia-related complications

Description

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.

Time Frame

2 hours postoperatively

Title

Sedation level

Description

Numeric Rating Scale will be applied to grade the pain where 0 = no pain and 10 = extreme pain.

Time Frame

2 hours postoperatively

Title

pain during and after the surgery

Description

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.

Time Frame

2 hours postoperatively

Title

Need for additional anesthesia during surgery and surgeon

Description

The dose of additional needed anesthesia (fentanyl 0.5 µg/kg) during surgery will be recorded

Time Frame

During surgery

Title

Intraoperative difficulties

Description

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

Time Frame

2 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed F Algyar, MD

Phone

00201111645345

Ext

047

mohammad.algaiar@med.kfs.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed F Algyar, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mohammed Fouad Mohamed Algyar

City

Kafr Ash Shaykh

State/Province

Kafrelsheikh

ZIP/Postal Code

33516

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammed F Algyar, MD

Phone

00201111645345

Ext

047

mohammad.algaiar@med.kfs.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

Dexmedetomidine in Topical Versus Peribulbar Anesthesia for Cataract Surgery

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