Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic

NCT06600945 | Recruiting

• 1 other identifier: Peribulbar Anesthesia
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peribulbar Anesthesia

Outcome Measures

Primary Outcomes (1)

• Block quality

  Occurance of motor and sensory block

  Baseline

Secondary Outcomes (1)

• Block Success

  Baseline

Study Arms (3)

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

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

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

Interventions

Cataract surgery OTHER

With local anesthetic in peribulbar anesthesia

Group A atracurium group; Group M magnesium sulphate group; Group c control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both sexes and from 20 to 80 years

You may qualify if:

• Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).
• Patients aged 20-80 years. Both sexes. ASA physical status I\&II.

You may not qualify if:

• \- 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 .

Sponsors & Collaborators

• Dalia yousry Mohamed elsayed: lead
• Minia University: collaborator

Study Sites (1)

Dalia yousry mohamed

Minya, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Effect of addition of atracurium and magnesium sulphate to local anesthetic in peribulbar anesthesia

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Atracurium Versus Atracurium and Magnesium Sulphate as Adjuvants to Local Anesthetic for Peribulbar Anesthesia in Cataract Surgery

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2023
• Primary Completion: April 22, 2024
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)