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

Early Phase 1

Completed

• Conditions: Vitreoretinal Surgeries; Local Anesthesia
• Interventions: Drug: Neostigmine; Drug: Saline; Drug: Dexmedetomidine

• Registration Number: NCT06501352
• Lead Sponsor: Ain Shams University

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%)

Study Timeline

• Study First Submitted: 2023-01-10
• Study Start: 2023-01-20
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine group	Neostigmine	Patients in this group will receive Neostigmine in Local anesthesia mixture.
Control group	Saline	Patients in this group will receive saline (placebo) in Local anesthesia mixture.
Dexmeditomedine group	Dexmedetomidine	Patients in this group will receive Dexmeditomedine in Local anesthesia mixture.

Primary Outcome Measures

Name	Time	Method
Onset & Duration of sensory and motor block	12 hours	By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again

Secondary Outcome Measures

Name	Time	Method
Systolic & Diastolic Arterial Blood Pressure	12 hours	measuring it pre-operative , intra-operative \& post-operative
Heart rate	12 hours	measuring HR per minute pre \& intra \& post operative
Patient & Surgeon satisfaction	12 hours	No pain by VAS score ( from 0 to 10 as 0 no pain \& 10 maximum pain ) VAS score intraoperative to assess patient satisfaction \& surgeon satisfactory by longer duration of motor \& sensory block .

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt