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.: PACTR202004851598147 Date of Approval: 08/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of two different multimodal analgesic techniques for patients undergoing laparoscopic sleeve gastrectomy
Official scientific title Comparison of two different multimodal analgesic techniques for patients undergoing laparoscopic sleeve gastrectomy
Brief summary describing the background and objectives of the trial Multimodal analgesia has shown to improve pain management, lowers healthcare costs and allows earlier discharge. Providing efficient pain management impacts the society by improving quality of care and decreasing mortality after surgery. Multimodal analgesia is advocated for bariatric surgery with the aim of reducing opioid use. Ketamine is a phencyclidine derivative with N-Methyl-D-aspartate (NMDA) antagonistic properties. When used in small doses, it is an analgesic, anti-hyperalgesic and prevents opioid induced tolerance. A key advantage of ketamine in patients with morbid obesity is that it synergizes opioid and adds onto analgesia without suppression of respiratory drive or loss of airway tone. Dexmedetomidine is an alpha-2 blocker that has selectivity for alpha-2a receptors that have roles in analgesia and sedation. It also has the ability to provide anesthesia without causing apnea or losing airway tone, especially in a highly susceptible patient population, such as those with morbid obesity with OSA. When used in low doses, it causes minimal hemodynamic or respiratory compromise.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/04/2020
Actual trial start date
Anticipated date of last follow up 15/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine 0.4 µg/kg/hr 24 hours dexmedetomidine infusion which will be started immediately after induction and will be discontinued at the start of wound closure. 35
Control Group Ketamine loading dose of intravenous ketamine (0.5 mg/kg) followed by 0.15 mg/kg/h infusion 24 hours a loading dose of intravenous ketamine which will be given immediately after induction followed by infusion that will be stopped 45 min before emergence. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesia (ASA) II&III. Allergy to any of the study medications. Revision or complicated surgery. Severe pulmonary, liver, renal or cardiovascular diseases. Patients with psychiatric disorder. Pre-existing acute or chronic pain. Previous abdominal surgery. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 29/05/2019 Menofia University Faculty of Medicine Research Thics Committe
Ethics Committee Address
Street address City Postal code Country
Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total opioid consumption 24 hours postoperative
Primary Outcome Postoperative pain score 24 hours postoperative
Secondary Outcome Intraoperative hemodynamic stability Intraoperative and 24 hours postoperative
Secondary Outcome postoperative complications 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Monofia University Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Mahmoud Soliman Yakout 397 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesiology and Surgical Intensive Care Faculty of Medicine Menoufia University Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hatem Amin Atalla Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
Ezzeldin Saleh Ibrahim Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
Amany Ammar Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
Hatem Baghat Ahmed Abo Elwafa 370 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
Maha Mahmoud Soliman Yakout 397 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
Nadia M Bahgat Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street Shebin elkoom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ezzeldin Saleh Ezzeldin7@yahoo.com 00201006303178 Yssin Abdel Ghaffar Street from Gamal Abdelnasser Street
City Postal code Country Position/Affiliation
Shebin elkoom 32511 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Menofia Univlersity
Role Name Email Phone Street address
Scientific Enquiries Hatem Abo Elwafa hatem_wafa@hotmail.com 00201155497711 370 ElHorreya Avenue Mustafa Kamel
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Lecturer of Anaesthesia and Surgical Intensive Care Faculty of Medicine Menofia Univlersity
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information