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.: PACTR201510001277321 Date of Approval: 26/09/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Magnesium sulfate and intraocular pressure
Official scientific title Intraocular pressure changes following administration of suxamethonium and endotracheal intubation: Influence of two different doses of magnesium sulfate
Brief summary describing the background and objectives of the trial Various methods have been used to attenuate the effects of suxamethonium and endotracheal intubation on IOP.Magnesium is the fourth most common cation in the body, and it activates approximately 300 enzymes systems. It acts as an adrenergic antagonist and inhibits the catecholamine release. So it probably controls the undesirable effects of suxamethonium and endotracheal intubation such as increased intraocular pressure, heart rate and blood pressure. This study aimed to evaluate the efficacy of 30mg and 50 mg of intravenous magnesium sulphate for the prevention of IOP rise by suxamethonium and intubation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/01/2015
Actual trial start date 01/12/2014
Anticipated date of last follow up 24/08/2015
Actual Last follow-up date 31/07/2015
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants) 120
Recruitment status Completed
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 An online randomization program was used to generate random number list. Patient randomization numbers were concealed in opaque envelopes that were opened by the study investigator. 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 C received 100 ml normal saline infusion infused over 10 minutes and 5 minutes before induction of general anesthesia. 40 Placebo
Experimental Group Group M1 received 30mg/kg magnesium sulphate in 100 ml normal saline infusion infused over 10 minutes and ended 15 minutes before induction of general anesthesia. 40
Experimental Group Group M2 received 50mg/kg magnesium sulphate in 100 ml normal saline infusion infused over 10 minutes and ended 5 minutes before induction of general anesthesia. 40
Control Group Group C received 100 ml normal saline infusion infused over 10 minutes and 15 minutes before induction of general anesthesia. 40 Placebo
Experimental Group Group M2 received 50mg/kg magnesium sulphate in 100 ml normal saline infusion infused over 10 minutes and ended 15 minutes before induction of general anesthesia. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
120 patients, their ages ranged between 18 and 60 years, ASA physical status class I and II underwent elective cataract surgery. known hypersensitivity to magnesium sulphate or succinylcholine hypocalcaemia any degree of heart block hypertensive obese (BMI >30) any cardiovascular, renal, hepatic or muscular disease patients with raised IOP previous eye surgery patients receiving any drug known to alter IOP 18 Year(s) 60 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 04/01/2015 Benha faculty of medicine- benha university
Ethics Committee Address
Street address City Postal code Country
Farid Nada st. Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraocular pressure (IOP) before study solution infusion (T0), before induction of general anesthesia (T1), after propofol and before succinylcholine (T2), 2minutes after tracheal intubation (T3) and 5 minutes from tracheal intubation (T4)
Secondary Outcome - Hemodynamic parameters: heart rate (HR) and mean arterial blood pressure (MAP). before study solution infusion (T0), before induction of general anesthesia (T1), after propofol and before succinylcholine (T2), 2minutes after tracheal intubation (T3) and 5 minutes from tracheal intubation (T4)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university Farid Nada st. Benha Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha University University
COLLABORATORS
Name Street address City Postal code Country
Ophthalmic department Benha university Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com 00201005204130 20 Ezz Eidin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Ahmed Tohamy atohamy80@gmail.com 00201008700759 Qaliob
City Postal code Country Position/Affiliation
Qaliob Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com 00201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information