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.: PACTR201607001699405 Date of Approval: 29/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sugammadex in children premedicated with dexamethasone
Official scientific title Recovery from rocuronium with sugammadex in children premedicated with dexamethasone for prevention of postoperative nausea and vomiting
Brief summary describing the background and objectives of the trial Sugammadex is a cyclodextrin specifically designed to reverse the action of rocuronium through encapsulation. Theoretically, it is possible that sugammadex can encapsulate cortisone. The primary outcome of the present study is to investigate any possible efficacy in alteration of sugammadex as a reversal of rocuronium due to dexamethasone injection in children undergoing strabismus surgery. The secondary outcome is to assess any possible side effects of sugammadex in these groups of patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Recovery from premedication,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/08/2015
Actual trial start date 15/08/2015
Anticipated date of last follow up 16/04/2016
Actual Last follow-up date 16/04/2016
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Randomised Simple randomisation using closed en Open-label(Masking Not Used)
Randomised Simple randomisation using coin tossing 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 Dex once Intraoperative Intravenous injection 40
Control Group Metoclopromide Once Intraoperative Intravenous injection 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I and II patients 1-6 years strabismus surgery Difficult airway Neuromuscular cardiac disease Hepatic disease Renal disease Metabolic disorder Steroidal or non-steroidal therapy 1 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 15/07/2015 Ethical committee of Alexandria Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Champollion Street Alexandria 26051 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Investigate any possible efficacy alteration of sugammadex as a reversal of rocuronium due to dexamethasone injection in children undergoing strabismus surgery Postoperative
Secondary Outcome Assess the safety of sugammadex in these groups of patients through close monitoring of the patients in the operating room and the Post Anesthesia Care Unit (PACU) 2 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Faculty of Medicine Alexandria, Alsultan Hussein st Alexandria 26051 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self fund
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria Faculty of Medicine Alsultan Hussein st Alexandria 26051 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Moustafa Abdelaziz Moustafa Smouha, Antoniadis city compound C2B7 Alexandria 21031 Egypt
Rabab Saber Saleh Alexandria Faculty of Medicine, Anesthesia Department Alexandria 26051 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Moustafa m.3abdelaziz@hotmail.com +201222373407 Smouha, Antoniadis City Compound, C2B7
City Postal code Country Position/Affiliation
Alexandria 26051 Egypt Alexandria Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Maha Ghanem maha.ghanem@alexmed.edu.eg +201223374415 Champolion st. , Alazarita
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Alexandria Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Nagwa Elkobbia kobbia@yahoo.com +201223368233 Alsultan Hussein st, Alexandria Faculty of Medicine, Anesthesia Department
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Alexandria Faculty of Medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information