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NCT Number: NCT06600945

Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalia yousry mohamed

Minya, Egypt

Location status: Recruiting

Location contact

Dalia Yousry Mohamed, Resident

CONTACT

[email protected]

01024044974

Mohamed Moustafa Ali

CONTACT

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Cataract surgery

Other

With local anesthetic in peribulbar anesthesia

Primary outcomes

  1. Block quality

    Time frame: Baseline

    Occurance of motor and sensory block

Secondary outcomes

  1. Block Success

    Time frame: Baseline

    Onset and duration of block.Post operative analgesia and pain score. Patient satisfaction and surgeon Satisfaction. Incidence of complications.

Sponsors and collaborators

Lead sponsor

Dalia yousry Mohamed elsayed

Other

Collaborators

  • Minia University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.