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.: PACTR201608001711322 Date of Approval: 10/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Two Different Doses of Magnesium sulphate as Adjuvant to Ropivacaine in peribulbar block for cataract surgery
Official scientific title Effect of Two Different Doses of Magnesium sulphate as Adjuvant to Ropivacaine in peribulbar block for cataract surgery
Brief summary describing the background and objectives of the trial 7. To compare the effects of adding two different doses of MgSO4 to ropivacaine as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia, pain score and IOP in peribulbar anaesthesia in cataract surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,cataract surgery,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2016
Actual trial start date 01/06/2016
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date 31/07/2016
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 computer-generated randomization sequence Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I (Control group) 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 2 ml of normal saline. patients received peribulbar anesthesia using a mixture of 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 2 ml of normal saline. 35 Placebo
Experimental Group Group II (Mg 50) 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase(Hyalase) and 50 mg of magnesium suphate in 1ml saline 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase (Hyalase® 1500 IU, Wockhardt, UK) and 50 mg of magnesium suphate in 1ml saline 35 Active-Treatment of Control Group
Experimental Group Group III (Mg100) 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1ml of 100mg magnesium sulphate. 5 ml of 0.5% ropivacaine, 1ml (150 IU) hyaluronidase and 1ml of 100mg magnesium sulphate. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were eligible for inclusion if they were ASA I¿III and undergoing routine cataract extraction surgery in Tanta University Hospital communication or language problems, history of allergy to amide local anaesthetic agents or hyaluronidase, known anatomical abnormalities or pre-existing extra-ocular muscle palsy., severe systemic disease, active ocular infection, single eye, who were pregnant, coagulopathy or those taking anti-coagulants, anti-epileptic drugs, anti-psychotic medication, anti-glaucoma drugs, atrioventricular block, , and obstructive apnea 40 Year(s) 70 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 01/06/2016 Tanta Univercity, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Elbahr Street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome akinesia score of the occular muscels at 3,5and10 min after injection
Primary Outcome duration sensory and motor block assessed by onset of pain and recovery of eyeball movement respectively.
Secondary Outcome total volume of local anesthetic to reach complete block
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hospital Elbahr Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univercity hospital anaesthesia department Elbahr Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity hospital anaesthesia department Elbahr Street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mona Mohammed Mogahed Elmoatasem Street Tanta Egypt
Wesam Mohammed Aboelazm Nassar Omar Ben Abd ElAziz Street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical Intensive care Faculty of medicine Tanta Universit
Role Name Email Phone Street address
Public Enquiries Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Anesthesia and Surgical Intensive Care, Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Wesam Nassar wessamnassar@gmail.com 00201023800060 Omar Bin AbdElaziz Street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta University
REPORTING
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Changes to trial information