Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic

NCT ID: NCT06600945

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-04-01

Brief Summary

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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

Detailed Description

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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 .

Conditions

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Peribulbar Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cataract surgery

Intervention Type OTHER

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 .

Cataract surgery

Intervention Type OTHER

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

Cataract surgery

Intervention Type OTHER

With local anesthetic in peribulbar anesthesia

Interventions

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Cataract surgery

With local anesthetic in peribulbar anesthesia

Intervention Type OTHER

Eligibility Criteria

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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 .
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role collaborator

Dalia yousry Mohamed elsayed

OTHER

Sponsor Role lead

Responsible Party

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Dalia yousry Mohamed elsayed

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dalia yousry mohamed

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Dalia Yousry Mohamed, Resident

Role: primary

01024044974

Mohamed Moustafa Ali

Role: backup

Other Identifiers

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Peribulbar Anesthesia

Identifier Type: -

Identifier Source: org_study_id

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