Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301561099017 Date of Approval: 31/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between rocuronium and magnesium sulfate as adjuvants to regional anesthesia for ophthalmic surgeries using peribulbar block
Official scientific title Comparative study between rocuronium and magnesium sulfate as adjuvants to regional anesthesia for ophthalmic surgeries using peribulbar block
Brief summary describing the background and objectives of the trial Peribulbar eye block is a safe and inexpensive technique with the advantage of providing efficient anesthesia with good globe and lid akinesia (Hamawy et al, 2018). It is also an effective treatment for peri-operative pain. Due to lack of a specific drug that inhibits nociception without associated side effects, it has become common practice to use the pharmacological approach to enhance the effect of the block. This study was designed to compare the effects of magnesium sulphate vs. rocuronium co-administered as adjuvants to peribulbar block local anesthesia. This study aims to compare the effect of adding magnesium sulfate versus rocuronium to standard local anesthetics mixture in peribulbar block in ophthalmic surgeries and assessment of the effect of this mixture on the time of onset of globe and lid akinesia and corneal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/09/2018
Actual trial start date 04/09/2018
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group O local anesthetic (9ml of the local anesthetic: 4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration)+0.9% saline (1 ml) After sterilization, 5ml of solution will be injected into each of the following two sites: infero-temporal and medial canthus peribulbar areas, separated by an adequate gentle orbital massage for at least 40 seconds. The injection will be administered using a 25G short bevel needle (25mm in length). Gentle orbital compression will then be performed for 1 min to aid in the diffusion of the local anesthetic mixture and also to soften the eye before surgery. In Group O: Conventional peribulbar anesthetic block will be performed in all patients using local anesthetic mixture (4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration) (9 ml) + 0.9% saline (1 ml). 25 Active-Treatment of Control Group
Experimental Group Group M 9ml of the local anesthetic: 4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration. Group M: local anesthetic+50mg magnesium sulphate in 1ml of 0.9% saline (Sirvinskas E, Laurinaitis R, 2002). After sterilization, 5ml of solution will be injected into each of the following two sites: infero-temporal and medial canthus peribulbar areas, separated by an adequate gentle orbital massage for at least 40 seconds. The injection will be administered using a 25G short bevel needle (25mm in length). Gentle orbital compression will then be performed for 1 min to aid in the diffusion of the local anesthetic mixture and also to soften the eye before surgery. In Group M: Conventional peribulbar anesthetic block will be performed in all patients using local anesthetic mixture (4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration) (9 ml) + 50 mg magnesium sulphate in 1ml of 0.9% saline (Sirvinskas E, Laurinaitis R, 2002). 25
Experimental Group Group R 9ml of the local anesthetic: 4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration. Group R: local anesthetic+0.06 mg/kg rocuronium (maximum 5 mg) in 1ml saline (Friedman DS et al, 2004). After sterilization, 5ml of solution will be injected into each of the following two sites: infero-temporal and medial canthus peribulbar areas, separated by an adequate gentle orbital massage for at least 40 seconds. The injection will be administered using a 25G short bevel needle (25mm in length). Gentle orbital compression will then be performed for 1 min to aid in the diffusion of the local anesthetic mixture and also to soften the eye before surgery. In Group R: Conventional peribulbar anesthetic block will be performed in all patients using local anesthetic mixture (4.5 ml of 0.5% bupivacaine and 4.5 ml of 2% lidocaine mixed with hyaluronidase (150 U) to accelerate tissue penetration) (9 ml) + 0.06 mg/kg rocuronium (maximum 5 mg) in 1ml 0.9% saline (Friedman DS et al, 2004). 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of both sexes who are candidates for cataract surgery. Age between 40 and 80 years. American Society of Anesthesiologists physical status score of I–III. Participants are enrolled from January 2019 to April 2020 at Ain Shams University Hospitals. Patients Known to have any systemic contraindications (as severe hypertension) or allergy to the local anesthetic. Those who refused local anesthesia. High myopes (axial length > 26 mm). Those with a single eye. Those with complicated vitreous hemorrhage. Those with ocular infection. Those with impaired orbital sensation. Those with retinal detachment. Those with expected prolonged surgery (> 2 hours). Patients with INR more than 1.4. Patients with platelets less than 100,000. Impaired consciousness or mental retardation. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/07/2018 Research Ethics committee at Faculty of medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Ramsis street - Abbassia squre Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lid akinesia at at 2.5, 5, 7.5, and 10min after injection.
Primary Outcome globe akinesia at 2.5, 5, 7.5, and 10min after injection.
Primary Outcome corneal anesthesia at 2.5, 5, 7.5, and 10min after injection.
Secondary Outcome Mean arterial blood pressure, heart rate, and oxygen saturation (SpO2) every 15min during the entire procedure and every 30 min during the first two postoperative hours.
Secondary Outcome visual analog scale (VAS) At the end of surgery
Secondary Outcome Time to start surgery (min) at 2.5, 5, 7.5, and 10min after injection.
Secondary Outcome Duration of surgery (min) at the end of surgery
Secondary Outcome Pain during surgery at the time of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine at Ain Shams university Ramsis street - abbassia square. Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Nagy Mohamed Alafifi alzohor street Obour City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine at Ain Shams university Ramsis street - Abbassia square Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Nagy Mohamed Alafifi noga_206@med.asu.edu.eg +201066000303 alzohor
City Postal code Country Position/Affiliation
Obour City Egypt Assistant Lecturer of Anesthesiology at faculty of medicine
Role Name Email Phone Street address
Public Enquiries Ossama Mansour viced.research@med.asu.edu.eg +20224346344 Ramsis street
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Vice Dean of research committee at faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Amr Helal amr_helal@med.asu.edu.eg +201001479037 Nasr street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Anesthesiology at faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes I agree and I am willing to share Individual participant data. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Study protocol is planned also to be shared. IPD will be available Beginning 3 months following article publication and No end date. It will be available to Anyone who wishes to access the data and for any analytic purpose. Data will be available indefinitely at (Link to be included). Study Protocol IPD will be available Beginning 3 months following article publication and No end date. It will be available to Anyone who wishes to access the data and for any analytic purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information