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

NCT06501352 | Completed Early Phase 1 DMC

• 1 other identifier: Ain Shams University Hospitals
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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 .

Conditions

Vitreoretinal Surgeries; Local Anesthesia

Keywords

Dexmeditomedine; Neostagmine; Peribulbar block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Systolic & Diastolic Arterial Blood Pressure

  12 hours

• Heart rate

  12 hours

• Patient & Surgeon satisfaction

  12 hours

Study Arms (3)

Dexmeditomedine group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Neostigmine group

ACTIVE COMPARATOR

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

Drug: Neostigmine

Control group

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Dexmedetomidine DRUG

Additive to Local anesthetic mixture

Also known as: Marcaine, Xylocaine, Hyaluronidase

Dexmeditomedine group

Neostigmine DRUG

Additive to Local anesthetic mixture

Also known as: Marcaine, Xylocaine, Hyaluronidase

Neostigmine group

Saline DRUG

Control

Also known as: Marcaine, Xylocaine, Hyaluronidase

Control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Lidocaine; Hyaluronoglucosaminidase; Neostigmine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: July 15, 2024
• Study Start: January 20, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 month
• Access Criteria: husseinhamdy@med.asu.edu.eg

Locations

EG (1)