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.: PACTR201710002663258 Date of Approval: 03/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Muscle relaxation during laparoscopic surgeries of morbidly obese patients
Official scientific title Deep versus moderate neuromuscular blockage in anesthesia for morbidly obese patients presented for laparoscopic bariatric surgery: Effect on surgical conditions and pulmonary complications
Brief summary describing the background and objectives of the trial Morbid obesity is associated with a decrease in the intra-abdominal space which represents one of the limiting factors on performing laparoscopic surgeries. The introduction of non-depolarizing muscle relaxants in clinical practice contributed to the Evolution in the anesthetic and surgical management of patients. The adequate use of non-depolarizing muscle relaxants allows the anesthetist to achieve a satisfactory operative goal while minimizing the doses of inhalational or intravenous anesthetics use. For a long period of time, maintaining deep neuromuscular block for optimizing surgical conditions was considered hazardous owing to the potential risk of awareness and residual curarisation in the postoperative period. Recent literature of Kopman revealed that deep neuromuscular block provides satisfactory surgical conditions during laparoscopy. However, there is a limited evidence of this statement.However, the main risk of the deep neuromuscular block is the increased risk of postoperative complications due to residual muscle. On anesthetizing morbid obese patients for laparoscopic surgeries, the controversy is usually exist about adjusting the dose of neuromuscular blockers for maintaining satisfactory surgical exposure while decreasing the risk of postoperative pulmonary complications.The new reversal agent of muscle relaxants, sugammadex 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anesthesia for morbid obese patients,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/10/2017
Actual trial start date
Anticipated date of last follow up 14/04/2018
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using computer generated software Sealed closed envelops Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Deep NM block group 0.6 mg/kg (lean body weight)/hr throughout the operative period Deep neuromuscular block group 30
Experimental Group Moderate NM block group 10mg increments of rocuronium Repeated throughout the whole operative period Moderate neuromuscular block 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 -BMI > 40 kg/m2 ¿ 50 kg/m2 -Scheduled for laparoscopic surgeries. -Pregnant or lactating -Suffer from neuromuscular or skeletal disorders -With known or suspected allergy to rocuronium -Psychologically unstable -With moderate or severe OSA -Had a history of congestive heart failure or renal failure. 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 17/08/2017 Tanta Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Algeish st Tanta 31511
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative surgical exposure Immediately after abdominal insufflation
Secondary Outcome Postoperative pulmonary function Immediately postoperative in the recovery room
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospitals 1, Algeish st Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohey Eldien Abu-Zeid Al-estad st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Abdelkhalik samehabdelkhalik1982@gmail.com 002010029770748 Moheb st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Anesthesia and Intensive Care- Faculty of Medicine- Tanta University
Role Name Email Phone Street address
Public Enquiries Amr Eid amr_eid_81@yahoo.com 00201277735156 Al Fateh st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Trainer at Tanta Sporting Club
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