Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries

NCT ID: NCT06501352

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2024-03-30

Brief Summary

The majority of patients undergoing ophthalmic surgeries are elderly, with multiple chronic diseases, with increased risk of morbidity and mortality under general anesthesia.

Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries.

Dexmedetomidine is a highly selective alpha-2 adrenoceptor. It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant, it will provide better anesthetic quality as well as prolongation of postoperative analgesia .

Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings .

Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia

& prolong duration .

Detailed Description

81 participants divided into three groups 27 patient in each group with inclusion criteria :

• Patients aged from 21 to 60 years.
• Patients ASA I to II undergoing Vitreoretinal Surgeries.
• Patient with axial globe length below 26 mm.
• Patients consented with Local anesthesia.

The three groups:

group I : will receive Peribulbar anesthesia block via 25G needle is inserted transcutaneously through the inferotemporal approach at the junction between the medial two third and the lateral third of the lower orbital margin in such a way the bevel is facing the globe and the tip towards the floor of the orbit until the needle passes through the orbital septum it is directed then posteriorly tangential to the floor of the orbit for 25mm length at which the 8 ml local anesthetic mixture is injected ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml of Dexmedetomidine equivalent to 25 mcg).

Ocular compression is applied for 5 minutes by Honan intraocular pressure IOP reducer adjusted at 20mmHg.

Group II :

Will recieve ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml of Neostigmine equivalent to 0.5 mg)

Group III :

( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml Normal Saline 0.9%)

Conditions

Vitreoretinal Surgeries; Local Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Dexmeditomedine group

Patients in this group will receive Dexmeditomedine in Local anesthesia mixture.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Additive to Local anesthetic mixture

Neostigmine group

Patients in this group will receive Neostigmine in Local anesthesia mixture.

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

Additive to Local anesthetic mixture

Control group

Patients in this group will receive saline (placebo) in Local anesthesia mixture.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Control

Interventions

Dexmedetomidine

Additive to Local anesthetic mixture

Intervention Type: DRUG

Neostigmine

Additive to Local anesthetic mixture

Intervention Type: DRUG

Saline

Control

Intervention Type: DRUG

Other Intervention Names

Marcaine; Xylocaine; Hyaluronidase; Marcaine; Xylocaine; Hyaluronidase; Marcaine; Xylocaine; Hyaluronidase

Eligibility Criteria

Inclusion Criteria

• Patients aged from 21 to 60 years.
• Patients ASA I to II .
• Patient with axial globe length below 26 mm.
• Patients consented with Local anesthesia.

Exclusion Criteria

• Patient refusal.
• Patients below or above the age.
• Patients with bleeding disorders.
• Patient with axial globe length more than 26 mm.
• history of relevant drug allergy to any of the used drugs

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hussein Hamdy

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Ain Shams University Hospitals

Identifier Type: -

Identifier Source: org_study_id