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

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 .

Study Overview

• Status: Completed
• Conditions: Local Anesthesia; Vitreoretinal Surgeries
• Intervention / Treatment: Drug: Saline; Drug: Dexmedetomidine; Drug: Neostigmine

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmeditomedine group; Patients in this group will receive Dexmeditomedine in Local anesthesia mixture.	Drug: Dexmedetomidine; Additive to Local anesthetic mixture; Other Names: Marcaine; Xylocaine; Hyaluronidase
Active Comparator: Neostigmine group; Patients in this group will receive Neostigmine in Local anesthesia mixture.	Drug: Neostigmine; Additive to Local anesthetic mixture; Other Names: Marcaine; Xylocaine; Hyaluronidase
Placebo Comparator: Control group; Patients in this group will receive saline (placebo) in Local anesthesia mixture.	Drug: Saline; Control; Other Names: Marcaine; Xylocaine; Hyaluronidase

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic & Diastolic Arterial Blood Pressure	measuring it pre-operative , intra-operative & post-operative	12 hours
Heart rate	measuring HR per minute pre & intra & post operative	12 hours
Patient & Surgeon satisfaction	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 .	12 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Peribulbar block; Dexmeditomedine; Neostagmine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cholinesterase Inhibitors; Parasympathomimetics; Dexmedetomidine; Lidocaine; Bupivacaine; Neostigmine
• Other Study ID Numbers: Ain Shams University Hospitals

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of work
• IPD Sharing Time Frame: 6 month
• IPD Sharing Access Criteria: husseinhamdy@med.asu.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No