Peribulbar AnesthesiaNCT06600945
Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic
An observational study of Peribulbar Anesthesia, run by Dalia yousry Mohamed elsayed at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peribulbar Anesthesia
- What is being tested?
- Cataract surgery
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both sexes and from 20 to 80 years
Who may be able to join
- Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).
- Patients aged 20-80 years. Both sexes. ASA physical status I\&II.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Dalia yousry mohamed
Minya
Dalia Yousry Mohamed, Resident, 01024044974, daliayousry883@gmail.com
Mohamed Moustafa Ali
About this study
Official title: 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
Read the 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 .
- Conditions
- Peribulbar Anesthesia
- Being tested
- Cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryOther
With local anesthetic in peribulbar anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 . Receives: 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 Receives: Other: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block quality
Occurance of motor and sensory block
Measured: Baseline
Secondary outcomes (1)
Block Success
Onset and duration of block.Post operative analgesia and pain score. Patient satisfaction and surgeon Satisfaction. Incidence of complications.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Feb 2023
- Primary completion22 Apr 2024
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peribulbar AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia yousry Mohamed elsayed
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Sponsor-investigator, Dalia yousry Mohamed elsayed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600945
- Sponsor's protocol ID
- Peribulbar Anesthesia
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atracurium Versus Atracurium and Magnesium Sulphate As Adjuvants to Local Anesthetic for Peribulbar Anesthesia in Cataract Surgery
- ClinicalTrials.gov ID
- NCT06600945
- Acronym / sponsor ID
- Peribulbar Anesthesia
- Conditions
- Peribulbar Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dalia yousry Mohamed elsayedUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group c control group | – | Other: Cataract surgeryGroup 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 |
| Group A atracurium group | – | Other: Cataract surgeryGroup 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 . |
| Group M magnesium sulphate group | – | Other: Cataract surgeryGroup 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both sexes and from 20 to 80 years
Key inclusion criteria (2 listed)
- Patients undergoing elective cataract surgery (phacoemulsification and intraocular lens implantation).
- Patients aged 20-80 years. Both sexes. ASA physical status I\&II.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract surgeryWith local anesthetic in peribulbar anesthesia | Other | Group A atracurium group, Group M magnesium sulphate group, Group c control group |
Primary outcome
Block quality
Time frame: Baseline
Occurance of motor and sensory block
1 secondary outcome
Block Success
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Peribulbar Anesthesia
Recruiting
Hemodynamic Effect of Dexmedetomidine Versus Magnesium Sulphate as an Adjuvant to Lidocaine in Preemptive Peribulbar Block in Patients Undergoing Dacryocystorhinostomy Under General Anesthesia
Hemodynamic Effect, Dexmedetomidine
Not yet recruiting
Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery
Vitreoretinal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peribulbar Anesthesia, run by Dalia yousry Mohamed elsayed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block quality (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.