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.: PACTR201601001421209 Date of Approval: 12/01/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravenous Magnesium Sulphate versus Dexamethasone during Sevoflurane Anesthesia
Official scientific title Effect Of Intravenous Magnesium Sulphate or Dexamethasone as Adjuvants to Sevoflurane Anesthesia During Primary Cleft Palate Repair
Brief summary describing the background and objectives of the trial Background: Emergence delirium (ED) is a frequent postoperative complication in young children undergoing cleft palate repair and it may be exacerbated by sevoflurane anesthesia. Objective: This study was undertaken to study the effect of magnesium sulphate or dexamethasone as adjuvants to sevoflurane in decreasing the delirium after primary cleft palate repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/11/2014
Actual trial start date 12/11/2014
Anticipated date of last follow up 18/10/2015
Actual Last follow-up date 18/10/2015
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 Computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Controlled group (group C) continue without any addition 30 Placebo
Control Group Controlled group (group C) continue without any addition 30 Placebo
Experimental Group Magnesium group (group M) 30 mg/kg loading dose on 10 minute then 10 mg/ kg every one hour though the operation 30
Experimental Group Dexamethasone group (group D) 0.15 mg/kg. single dose after induction. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children with incomplete cleft palate. 2- 6 years old. ASA I. Any family history with allergy to dexamethasone or magnesium. Any neurological disease. Any psychological problems. Disagreement of parents. 2 Year(s) 6 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 03/08/2014 Cairo faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Kasr Elainy st. Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The emergence of delirium was assessed using watcha score each 5 min postoperation
Secondary Outcome glucose level. postoperative
Secondary Outcome Heart rate and blood pressure Preinduction and every 10 min for 2 hours(T0 ¿ T12).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine - Cairo university Kasr Elainy st. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine - Cairo university Kasr Elainy st. Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of medicine Kasr Elainy st. Cairo Egypt Hospital
Primary Sponsor Cairo university Elgamaa st. Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Anesthesia department Kasr Elainy st. Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elsonbaty Jijsonbaty@yahoo.com +201000255200 Elharam st.
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Saad Saad saadibrahim_7@yahoo.com +201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com +201005204130 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information