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.: PACTR201703002147145 Date of Approval: 26/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title General Anesthesia For obese patients
Official scientific title Study of the Safety and the Efficacy of Rocuronium versus Cisatracurium for Rapid Sequence Induction of Anaesthesia in Morbidly Obese Patient: A comparative Randomized study.
Brief summary describing the background and objectives of the trial The anesthetists are frequently encountered with obese patients in the operating room. These patients may provide the anesthetist with a considerable challenge especially difficult airway management and increased risk of aspiration. Theses risk factors may necessitate rapid sequence induction of anesthesia even with elective surgeries. Traditionally, suxamethonium has been the neuromuscular blocking drug of choice in these cases because of its rapid onset of action and relative short duration. The use of suxamethonium can, however, be associated with many side¿effects including muscle pains, bradycardia, hyperkalemia, and raised intra¿ocular pressure. It may also acts as a trigger for malignant hyperthermia. There are many alternatives to suxamethonium for use during rapid sequence induction of anesthesia. There have been many studies looking at the equivalence of suxamethonium and non depolarizing neuromuscular agents like rocuronium and cisatracurium, with conflicting outcomes. Our rational is, the use of higher intubating dose of non depolarizing muscle relaxant like rocuronium and cisatracurium can fasten and facilitate the intubation process. The aim of this study is to assess the safety and the efficacy of rocuronium versus cisatracurium for rapid sequence induction of anesthesia in morbidly obese patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Morbid obesity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/03/2017
Actual trial start date 22/03/2017
Anticipated date of last follow up 03/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 60
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 generate randomisation sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rocuronium group (ROC) rocuronium 0.9 mg/kg once induction of anesthesia 30
Experimental Group Cisatracurium group (CIS) cisatracurium 0.15 mg/kg once induction of anesthesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
physical status ASAII&III age 20-40 BMI 40-50 kg/m2 scheduled for elective surgery Patient refusal to participate in research. Patients having major hepatic, renal, cardiovascular, pulmonary and neuromuscular diseases. Pregnant patients. Supermorbidant obese patient with BMI <50kg/m2. Known or suspected allergy to used drugs Patients who should be offered awake intubation. 20 Year(s) 40 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 29/04/2017 Research Ethics Committee of Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
1, Elgeish st, Tanta Tanta 31741 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of relaxation of both drugs 1-After induction of anesthesia 2- At laryngyscopy application 3- With introduction of endotracheal tube
Secondary Outcome Safety of both drugs (Heart rate, Mean arterial pressure) 1-T0: before induction (baseline) 2-T1: after induction and before injection of NMB. 3-T2: after injection of NMB and before endotracheal intubation. 4- T3: just after intubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital 1, Elgeish st, tanta Tanta 31741 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospital 1, Elgeish st, tanta Tanta 31741 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital 1, Elgeish st, tanta Tanta 31741 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sameh Abdelkhalik Ahmed Saied st Tanta 31741 Egypt
Salah Ibraheem Alsherif Ibn Elfared St Tanta 31741 Egypt
Nagat Sayed Elshmaa Elgeish st Tanta 31741 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Mohamed Taher emantaher6669@gmail.com 00201090822808 Algeish st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Resident of Anesthesiology- Tanta University Hospital
Role Name Email Phone Street address
Public Enquiries Fatheya Khairy Fatheya.khairy343l@gmail.com 00201222613077 Botros st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Employer at ministry of health
Role Name Email Phone Street address
Scientific Enquiries Abdelraheem Dowidar dr.dowidar@hotmail.com 00201223195015 Saied st
City Postal code Country Position/Affiliation
Tanta 31741 Egypt Professor of Anesthesiology and Surgical Intensive Care, Tanta University
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