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.: PACTR201804003260153 Date of Registration: 28/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rapid sequence induction in morbid obesity
Official scientific title The effect of the use of Vecuronium or Rocuronium as a rapid sequence induction for morbidly obese patients; A comparative Randomized Study
Brief summary describing the background and objectives of the trial There is a marked increase in the prevalence of morbid obesity. The prevalence of significant obesity continues to rise in both developed and developing countries and is associated with an increased incidence of medical and surgical pathologies. The anesthetic management of morbidly obese patients represent a challenge to most of the anesthesiologists. The most challenging risk in morbid obese patients is the increased likelihood of difficult airway management together with increased risk of aspiration. So, those patients require rapid sequence induction of anesthesia to secure the patient's airway smoothly and quickly, minimizing the chances of regurgitation and aspiration of gastric contents. The depolarizing neuromuscular agent, suxamethonium is the traditional neuromuscular blocking drug of choice in rapid sequence induction owing to its rapid onset of action and relatively short duration. However, many side effects and complication limit the use of suxamethonium especially muscle pains, bradycardia, hyperkalemia, and raised intraocular pressure. It may also act as a trigger for malignant hyperthermia. There are many available studies evaluating the use of different non depolarizing neuromuscular agents like rocuronium, vecuronium, and cisatracurium, instead of suxamethonium with conflicting outcomes. Sugammadex, the new reversal agent of muscle relaxants, allows complete and rapid reversal of rocuronium as compared to the traditional reversal by neostigmine. Thus, it may allow deep neuromuscular block during the intraoperative period for optimal surgical exposure and complete reversal of muscle relaxation for decreasing postoperative pulmonary complications. We aim to compare the use of rocuronium or vecuronium in rapid sequence induction in morbidly obese patients. Our primary out will be the onset of intubation, while, our secondary outcomes will be the intubation score and the incidence of complication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Rapid sequence induction in morbid obese patients,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 20/02/2018
Actual trial start date 24/02/2018
Anticipated date of last follow up 23/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomisation using a radomisation table created by a computer software program 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 Group (ROC) rocuronium 1.2 mg/kg at induction of anesthesia Once rapid sequence induction of anesthesia by rocuronium 30 Active-Treatment of Control Group
Experimental Group Group (VEC) vecuronium 0.15 mg/kg. during induction of anesthesia Once Rapid sequence induction of anesthesia by vecuronium 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-ASA II to III patients -Aged from 25 to 45 years old -Of both gender -With BMI > 40 kg/m2 ¿ 50 kg/m2 -Scheduled for elective surgeries - Patient refusal to participate in research. - BMI 50kg/m2. - Pregnant or lactating patients - Known or suspected allergy to the used medication - Major cardiac, hepatic, renal, or pulmonary morbidities 25 Year(s) 45 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 18/02/2018 Research Ethics Committee of Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
1, Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The onset of intubation -Once the TOF reaches more than 95% suppression
Secondary Outcome The intubation score -During the first trial of endotracheal intubation
Secondary Outcome The incidence of complications -At the end of the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Tanta University 1, Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Tanta University 1, Algeish st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Tanta University 1, Algeish st Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohey Eldien Abu-Elyazed Alestad st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@gmail.com 00201002977048 Saied st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Ahmed Elfayoumy elfayoumi@hotmail.com 00201094310605 Aldoky
City Postal code Country Position/Affiliation
Giza 12511 Egypt Secretary at the Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Sohair Soliman sohairsoliman@hotmail.com 00201283929049 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care- Tanta Faculty of Medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information