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.: PACTR201411000927335 Date of Registration: 04/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title the impact of continous infusion adjuvants on the quality of recovery after laparoscopic bariatric surgery: dexamedetomidine versus Lidocaine.
Official scientific title the impact of continous infusion adjuvants on the quality of recovery after laparoscopic bariatric surgery: dexameditomidine versus Lidocaine: a double blinded randomized, placebo controlled trial.
Brief summary describing the background and objectives of the trial enhancement of patient satisfaction improving their postoperative experience is crucial to improve the quality of care. Morbidly obese patients are considered to be a real challenge for preoperative pain control. High ceiling opioid analgesics have a limited role due to safety concerns in this type of patients. the use of dexameditomidine an alpha 2 agonist has been shown to decrease stress response, maintain hemodynamic stability and provide sedation without trace effect on respiratory functions. systemic Lidocaine on the other hand has anti-inflammatory and analgesic effects. We hypothesized that infusion of either dexameditomedine or lidocaine in the perioperative period will improve recovery quality and reduce opioids and their side effects in morbidly obese patients undergoing laparoscopic bariatric surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied improving anethesia recovery quality
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/12/2014
Actual trial start date 08/12/2014
Anticipated date of last follow up 15/05/2015
Actual Last follow-up date 24/05/2015
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexamidetomedine group loading dose 1ug/kg over 10 minutes in 10 cc syringe diluted with saline before induction of anesthesia followed by continous infusion of dexameditomidine 0.4uk/kg/hour in saline throughout the whole procedure perioperative dexameditomedine the medicine will be diluted in two syringes a 10 cc syringe for loading and a 20 cc syringe for continous infusion the concentration of the medicine in the syringes will be priorly adjusted to ideal body wieght of each patient. this will be done by the anethesia technichian who is not participating in care giving or outcome assessement 50
Experimental Group lidocaine group loading dose of 1.5 mg/kg over 10 minutes in 10 cc syringe prior to anesthetic induction followed by infusion of 2mg/kg/hour lidocain in saline throughout the whole procedure preoperative lidocaine the medicine will be diluted in two syringes a 10 cc syringe for loading and a 20 cc syringe for continous infusion the concentration of the medicine will be priorly adjusted to ideal body weight of each patient by anesthesia technician who is not participating in care giving or outcome assessement. 50
Control Group saline group loading dose of 10 cc plaine saline followed by continous infusion of saline throughout the procedure throughout the whole procedure preoperative saline will be aspirated in 10 cc and 20 cc syringes the 10 cc syringe will be used as a loading of placebo(saline) then a 20 cc syring will be used for infusion of saline at a rate of 10 ml / hour additional 20 ml syringes having the same content wii be available in case of prolonged surgery 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-ASA 1 and 2 morbidly obese patients with body mass index 40 and above. 2- both male and female patients 1- uncontrolled diabetes or uncontrolled hypertension. 2-allergic patients to either dexameditomedine or lidocaine 3-hepatic,renal or respiratory failure 4- smokers 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 20/10/2014 Menoufia university hospitals,ethics committee for clinical research
Ethics Committee Address
Street address City Postal code Country
Gamal abdel-nasser street, Shebin Elkom,Menoufia Egypt Shebin Elkom NA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome quality of recovery by 40 questionaire at 2,8,12,24 and 48 hours postoperatively
Secondary Outcome morphine consumption 2,4,8,12,24 and 48 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya university Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menofia University Gamal abdel-nasser street Shebin Elkom, Menoufia NA Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abeer sherif Alshatby Alexandria NA Egypt
Hazem Elsersy 89 saad Zagloul street Shebin Elkom, Menoufia NA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abeer shreif dr.abeersherif@hotmail.com 0096565129328 alshatby
City Postal code Country Position/Affiliation
Alexandria NA Egypt assistent professor of anethesia, menoufia university
Role Name Email Phone Street address
Public Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201091096655 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Hazem Elsersy hazelsersy@hotmail.com 00201091096655 89 Saad Zagloul street
City Postal code Country Position/Affiliation
Shebin Elkom NA Egypt Lecturer of Anethesia, Faculty of medicine,Menoufia University
REPORTING
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