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.: PACTR201608001667173 Date of Approval: 09/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine versus magnesium sulphate as an adjuvant to rocuronium bromide, and local anesthetic mixture in peribulbar anaesthesia for viteroretin
Official scientific title Dexmedetomidine versus magnesium sulphate as an adjuvant to rocuronium bromide, and local anesthetic mixture in peribulbar anaesthesia for viteroretinal surgery
Brief summary describing the background and objectives of the trial To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia, pain score and IOP in peribulbar anaesthesia in vitreoretinal surgery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,peribulbar anaesthesia in vitreoretinal surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2015
Actual trial start date 01/06/2015
Anticipated date of last follow up 01/08/2016
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 135
Actual target sample size (number of participants) 135
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 Using a computer¿generated randomization schedule and serially numbered, opaque, sealed envelopes, patients will be randomly allocated to one of three study groups; 45 patients in each group opaque and sealed envelopes. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Using a computer¿generated randomization schedule and serially numbered, opaque, sealed envelopes, patients will be randomly allocated to one of three study groups; 45 patients in each group opaque and sealed envelopes. Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 1(C group) 3.5ml bupivacaine 0.5%, 3.5 ml lidocaine 2%, 0.5ml rocuronium bromide (5mg) plus 0.5ml Normal saline (0.9% NaCl) each patient will receive the combination of 3.5ml bupivacaine 0.5%, 3.5 ml lidocaine 2%, 0.5ml rocuronium bromide (5mg) plus 0.5ml Normal saline (0.9% NaCl) 45 Placebo
Experimental Group Group 2( D group) 3.5ml bupivacaine0.5%, 3.5 ml lidocaine 2%, 0.5ml rocuronium bromide (5mg) plus 0.5ml Dexmedetomidine (50µ. ( 45
Experimental Group Group 3 ( M group) 3.5ml bupivacaine 0.5%, 3.5 ml lidocaine 2%, 0.5ml rocuronium bromide (5mg) plus 0.5ml MgSO4 5% (50mg ) each patient will receive the combination of 3.5ml bupivacaine 0.5%, 3.5 ml lidocaine 2%, 0.5ml rocuronium bromide (5mg) plus 0.5ml MgSO4 5% (50mg ) 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
96 patients, aging (40-65y), (ASA I&II) of both sex presented for viteroretinal surgery under local anesthesia in Tanta University Hospital Ophthalmology department. Patient with renal and liver diseases, Cardiovascular instability, Orthopnea, History of allergy to local anesthetics, Patient with coagulopathies and impaired platelet functions, Parkinsonism, claustrophobia, difficulty in communication, patients with high myopia, staphylomas, Local infection at the site of the block and extra¿ocular muscles or eyelid abnormalities will be excluded 40 Year(s) 65 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 01/05/2016 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 To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia ¿ The score of akinesia in the 1, 3, 5and 10 minutes after injection.(score 0 total, score 1 relative , score 2 no akinesia )
Primary Outcome To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia ¿ The score of akinesia in the 1, 3, 5and 10 minutes after injection.(score 0 total, score 1 relative , score 2 no akinesia )
Primary Outcome To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia ¿ The score of akinesia in the 1, 3, 5and 10 minutes after injection.(score 0 total, score 1 relative , score 2 no akinesia )
Secondary Outcome pain score and IOP in peribulbar anaesthesia in vitreoretinal surgery ¿ Intraoperative pain at the end of the surgery using a visual analogue scale (VAS)
Primary Outcome To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia ¿ The score of akinesia in the 1, 3, 5and 10 minutes after injection.(score 0 total, score 1 relative , score 2 no akinesia )
Primary Outcome To compare the effects of adding dexmedetomidine (DEX) or MgSO4 to rocuronium bromide as an adjuvant to local anesthesia mixture on the onset duration and degree of akinesia ¿ The score of akinesia in the 1, 3, 5and 10 minutes after injection.(score 0 total, score 1 relative , score 2 no akinesia )
Secondary Outcome pain score and IOP in peribulbar anaesthesia in vitreoretinal surgery ¿ Intraoperative pain at the end of the surgery using a visual analogue scale (VAS)
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 Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wesam Mohammed Aboelazm Nassar Tanta Egypt
Mohammad Ali Abdullah Tanta Egypt
Mona Mohammed Mogahed 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 University
Role Name Email Phone Street address
Scientific Enquiries Wesam Nassar wessamnassar@gmail.com 00201023800060
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine, Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohammad Abdullah moh_aly_2005@hotmail.com 00201099957971
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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