Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic

Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic for Peribulbar Anesthesia in Cataract Surgery

To evaluate the effects of adding magnesium sulfate to atracurium with local anesthetic mixture on akinesia of globe and eyelid regarding onset and duration in cataract surgery using peribulbar technique

Study Overview

• Status: Recruiting
• Conditions: Peribulbar Anesthesia
• Intervention / Treatment: Other: Cataract surgery

Detailed Description

Regional anesthesia is a preferred technique for ophthalmic surgery. It's safe, inexpensive and provides efficient ocular anesthesia for ophthalmic surgery.

Among regional blocks, peribulbar block is safe to retrobulbar block due to lesser incidence of series complications such as brain-stem anesthesia globe perfusion and retrobulbar hemorrhage .

The effect of non-depolarizing neuromuscular blockers on peribulbar anesthesia has been described in many studies. According to these studies the use of atracurium as adjuvant to peribulbar anesthesia provides early onset of akinesia and improves the quality of anesthesia in absence of any adverse effect.

Magnesium sulphate is non-competitive N-Methyl-D- Aspartate (NMDA) antagonism and calcium channel blocker. Magnesium has endothelium derived Nitric Oxide induced vasodilation. It enhanced the activity of local anesthetic agent and improves the quality of anesthesia .

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • Dalia yousry mohamed
    • Contact: Dalia Yousry Mohamed, Resident; Phone Number: 01024044974; Email: daliayousry883@gmail.com
    • Contact: Mohamed Moustafa Ali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Both sexes and from 20 to 80 years

Description

Inclusion Criteria:

• Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).

Patients aged 20-80 years. Both sexes. ASA physical status I&II.

Exclusion Criteria:

- Refusal of the patient to participate in the study. Any disorder of neuromuscular system known from history or clinical examination e.g., Guillarian barre syndrome, Myasthenia gravies and Myopathies.

Patients are known to have a history of fits. Patients on medication known to interact with neuromuscular blocking drugs as antipyretics (aminoglycosides and tetracyclines), antiarrhythmic (quinidine).

Local sepsis. Coagulation abnormalities (INR>1.4). High myopia with axial length more than 30 mm or less than 21. Mentally retarded patients and failure of proper communication as in deafness. Morbidly obese patients (BMI>40). Patients with glaucoma (increased IOP>20mmgh). Patients with history of hypersensitivity to study drugs. Very dense or very soft cataract .

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group c control group; Group C (Control group): Will undergo peribulbar block using 6ml of local anesthetic: 2ml of 0.5%bupivacaine and 1ml of 2% lidocaine mixed with hyaluronidase (150 U) + 2ml lidocaine 2 %+ 1ml 0.9% saline without atracurium and magnesium sulphate	Other: Cataract surgery; With local anesthetic in peribulbar anesthesia
Group A atracurium group; Group A (Atracurium group): Will undergo peribulbar block using 6ml of local anesthetic: 2ml of 0.5% bupivacaine and 1ml of 2% lidocaine mixed with hyaluronidase (150 U) + 2ml lidocaine 2%+ 0.05 mg/kg atracurium (maximum 5 mg) in 1 ml of 0.9% saline .	Other: Cataract surgery; With local anesthetic in peribulbar anesthesia
Group M magnesium sulphate group; Group M (Atracurium+ Magnesium sulfate): Will undergo peribulbar block using 6ml of local anesthetic: 2 ml of 0.5%bupivacaine and 1 ml of 2% lidocaine mixed with hyaluronidase (150 U) +2ml lidocaine2%+ (0.05 mg/kg atracurium (maximum 5 mg) + 50 mg magnesium sulfate) in 1 ml of 0.9% saline	Other: Cataract surgery; With local anesthetic in peribulbar anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block quality	Occurance of motor and sensory block	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block Success	Onset and duration of block.Post operative analgesia and pain score. Patient satisfaction and surgeon Satisfaction. Incidence of complications.	Baseline

Collaborators and Investigators

• Sponsor: Dalia yousry Mohamed elsayed
• Collaborators: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): April 22, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Peribulbar Anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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