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.: PACTR201701001958143 Date of Approval: 02/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of magnesium sulphate on intraocular pressure
Official scientific title The Effect Of Magnesium Sulphate In Attenuating The Upsurge Of Intraocular Pressure During Rapid Sequence Induction By Suxamethonium Chloride: A Prospective Double-Blinded Randomized Placebo Controlled Trial.
Brief summary describing the background and objectives of the trial The use of suxamethonium chloride for rapid sequence induction in patients with open globe injuries may be detrimental to the eye as it increases IOP transiently for 2 to 6 minutes by 10-20 mmHg. Several methods have been introduced to attenuate the effects of suxamethonium and endotracheal intubation on IOP surge as pre-treatment with a non-depolarizing muscle relaxant, use of nifedipine, nitroglycerin, clonidine, dexmedetomidine, narcotics, tranquilizers, and lidocaine with variable degree of successes and failures.(4,5) A lot of recent trials emphasized that perioperative magnesium sulphate infusion has a general anesthetic properties that could reduce anesthetic drug consumption and postoperative analgesia requirements in several types of surgery. These effects mediated through its antinociceptive properties as a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. In addition to its role in procedures that necessitate deliberate hypotension as it acted as a calcium channel blocker and direct vasodilator.(11,12) So it possibly controls the undesirable effects of suxamethonium and endotracheal intubation such as increased IOP, mean blood pressure, and heart rate.This study aimed to determine if the intravenous administration of magnesium sulphate (40 mg/kg) before the induction of anesthesia could attenuate the increase of IOP associated with rapid-sequence induction by suxamethonium injection and endotracheal intubation. We hypothesized that magnesium sulphate could be useful in the obtundance of IOP upsurge during endotracheal intubation after suxamethonium injection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Intraocular pressure rise after suxamethonium administration in rapid sequence induction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnesium sulphate administration 40mg /kg in 100 ml normal saline once 15 min before anaesthesia induction Intravenous infusion 50
Control Group Saline 100 ml Once 15 min before anesthesia induction Intravenous infusion over 20 min. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 18 - 95 years. ASA 1 and 2. Non-ophthalmic surgery. Rapid sequence induction anaesthesia. Patients with known hypersensitivity to magnesium sulphate or suxamethonium. Hypocalcemia. Any degree of heart block. Uncontrolled hypertension. Patients with unstable hemodynamics or in need to inotropes or vasopressor support. Morbidly obese (BMI ¿ 40). Any cardiovascular, renal, hepatic or muscular disease. Patients with raised IOP. Patients receiving any drug known to alter IOP. Previous eye surgery. Expected difficult intubation. Require two or more attempts at laryngoscopy for endotracheal tube placement. 18 Year(s) 95 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
No 14/01/2017 Ethics committee of faculty of medicine, Fayoum University.
Ethics Committee Address
Street address City Postal code Country
Said Soliman Street Fayoum 63514 Egypt
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 11/01/2017 Ethics committee of faculty of medicine, Fayoum University.
Ethics Committee Address
Street address City Postal code Country
Said Soliman Street Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraocular pressure (IOP) Before study solution infusion (T0). After study solution infusion and just before induction of general Anesthesia (T1). After propofol and before suxamethonium (T2). Two minutes after tracheal intubation (T3). Five minutes after tracheal intubation (T4).
Secondary Outcome Mean arterial blood pressure (MAP) Before study solution infusion (T0). After study solution infusion and just before induction of general Anesthesia (T1). After propofol and before suxamethonium (T2). Two minutes after tracheal intubation (T3). Five minutes after tracheal intubation (T4).
Secondary Outcome Heart rate (HR) Before study solution infusion (T0). After study solution infusion and just before induction of general Anesthesia (T1). After propofol and before suxamethonium (T2). Two minutes after tracheal intubation (T3). Five minutes after tracheal intubation (T4).
Secondary Outcome Laryngoscopy time During laryngoscopy
Secondary Outcome serum magnesium level One hour after completion of study drug administration.
Secondary Outcome body mass index (BMI) once
Secondary Outcome ASA once
Secondary Outcome Age once
Secondary Outcome Weight once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospital Said Soliman Street. Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hany Mahmoud Yassin 303t, Hadaek Al-Ahram, Giza Giza 12572 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Yassin hmy00@fayoum.edu.eg 0020 1111 3636 02 303t, Hadaek Al-Ahram, Giza
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Public Enquiries Yasser Salim yasser.salem@yahoo.com 0020 1009 3141 78 Sheikh Amer st.
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Assisstant lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Mahdy Abd Elhady mahdyanesthesia@yahoo.com 0020 1024 6060 06 Sheikh Amer st.
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Assisstant lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
REPORTING
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