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.: PACTR201702002030563 Date of Approval: 10/02/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Total Intravenous Anesthesia with Propofol for Laparoscopic Gastric Bypass Surgery: Dexmedetomidine versus Fentanyl
Official scientific title Total Intravenous Anesthesia with Propofol for Laparoscopic Gastric Bypass Surgery: Dexmedetomidine versus Fentanyl
Brief summary describing the background and objectives of the trial The choice of anesthetic technique for general anesthesia in morbidly obese patients remains controversial. Because of concern that opioids might cause perioperative respiratory depression.The aim of this study is to compare the efficacy of dexmedetomidine versus fentanyl infusion during general anesthesia using total intravenous anesthesia with propofol in laparoscopic gastric bypass surgery as regard to heamodynamics, recovery profile and postoperative analgesia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,obesity,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/07/2016
Actual trial start date
Anticipated date of last follow up 01/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 64
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
30833/03/16 Research ethics committee, Faculty of Medicine, Tanta Universityd, Egypt
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group total intravenous anesthesia plus fentanyl infusion Fentanyl (1 ug/kg) before induction of anesthesia as loading dose followed by continous infusion after intubation and will be stopped 10 minutes before the end of surgery. Fentanyl (1 ug/kg) will be given intravenously before induction of anesthesia as loading dose followed by continous infusion at a rate of (1ug/kg/hr) after intubation and will be stopped 10 minutes before the end of surgery plus propofol infusion at rate 10mg/kg/ hr for the first 10 min, 8 mg/kg/hr for the next 10 min, 5¿6 mg/kg/hr for the duration of the procedure and 2mg/kg/hr at skin clousure. 32 Active-Treatment of Control Group
Experimental Group total intravenous anesthesia plus dexmedetomidine infusion 0.5 ug/kg before induction of anesthesia as loading dose followed by continous infusion after intubation and will be stopped 10 minutes before the end of surgery dexmedetomidine 0.5 ug/kg will be given before induction of anesthesia as loading dose followed by continous infusion at a rate of (0.5 ug/kg/hr) after intubation and will be stopped 10 minutes before the end of surgery plus propofol infusion at rate 10mg/kg/hr for the first 10 min, 8 mg/kg/hr for the next 10 min, 5¿6 mg/kg/hr for the duration of the procedure and 2mg/kg/hr at skin clousure. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- ASA physical status I &II. 2- Both sexes, age from 20 to 40 years old. 3- BMI ¿ 35 kg/m2. (1) Allergy to ¿2 -adrenergic agonist or sulfa drugs. (2) History of myocardial disease. (3) Clinically significant neurologic, renal, hepatic, or gastrointestinal diseases. (4) Opioid medication within 24 hours before the operation. 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
Yes 16/03/2016 research ethics committe faculty of medicine tanta university
Ethics Committee Address
Street address City Postal code Country
El Gaish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1-Heamodynamic stability In both groups mean arterial blood pressure (MAP) and heart rate (HR) will be recorded (baseline, before induction, before intubation, after tracheal intubation, at skin incision, at regular intervals throughout the surgery (every 30 minutes) until the end of surgery
Primary Outcome 2-The recovery profile after anesthesia
Secondary Outcome Postoperative pain every 2 hour for 12 hours
Secondary Outcome O2 saturation Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals ElGaish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Tanta University ElGaish street tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Anesthesia department Faculty of medicine tanta university ElGaish street tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Alaa Mohammad Fathi Abo-Hagar El Gaish street tanta 31527 Egypt
Mohammad Ibrahem Okab El Azhar street from El Helw street Tanta 3125 Egypt
Sabry Mohammad Amen Tot angh amon Tanta 3125 Egypt
Sameh Abdelkhalik Ahmed El Fateh street Tanta 3125 Egypt
Mohammad Ibrahem Okab El Azhar street from El Helw street Tanta 3125 Egypt
Sabry Mohammad Amen Tot angh amon Tanta 3125 Egypt
Sameh Abdelkhalik Ahmed El Fateh street Tanta 3125 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator alaa abohagar alaaabohagar@yahoo.com 0201099220281 Ahmed elshaarawy from elGaish street
City Postal code Country Position/Affiliation
tanta 31527 Egypt Assistant lecturer of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Sameh Abdelkhalik Ahmed dr_sameh_100@yahoo.com 0201002977048 Elfateh
City Postal code Country Position/Affiliation
Tanta 3125 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Sabry Mohammad Amen sabry.hamouda@med.tanta.edu.eg 0201141315877 Tot angh amon
City Postal code Country Position/Affiliation
Tanta 3125 Egypt Assistant Professor of Anesthesia & Surgical Intensive care unit
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
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