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.: PACTR201606001662120 Date of Approval: 05/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study between the effects of lidocaine infusion, magnesium infusion or dexemedetomidine infusion on haemodynamic responses and postoperati
Official scientific title Comparative Study between the effects of lidocaine infusion, magnesium infusion or dexemedetomidine infusion on haemodynamic responses and postoperative outcome in laparoscopic cholecystectomy
Brief summary describing the background and objectives of the trial The primary aim of this study is to compare the effects of using intraoperative dexemedetomidine, magnesium or lidocaine infusion on haemodynamic stress response to laryngoscopy , endotracheal intubation, creation of Pneumoperitoneum, and extubation in laparoscopic cholecystectomy. The secondary aim is to show their effects on extubation time, postoperative analgesic requirements, sedation score and adverse outcome
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,laparoscopic cholecystectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2015
Actual trial start date 01/06/2015
Anticipated date of last follow up 01/08/2016
Actual Last follow-up date 01/08/2016
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
Recruitment status 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
Randomised Using a computer¿generated randomization schedule and serially numbered, opaque, sealed envelopes, patients will be randomly allocated to one of three study groups; 32 patients in each group . opaque, sealed envelopes, patients will be randomly allocated to one of three study groups; 32 patients in each group . Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group1:Lidocaine group (group L) a bolus of 25 ml (1.5mg/kg of lidocaine diluted by normal saline) followed by continuous infusion of 1.5mg/kg/h lidocaine Bolus doses will be given over 10 min prior to initiation of anesthesia followed by infusion till the end of the surgery .(for a maximum of 180 min Bolus doses will be given over 10 min prior to initiation of anesthesia followed by infusion till the end of the surgery .(for a maximum of 180 min to avoid lidocaine toxicity). After termination of the bolus dose, the patients will be oxygenated by 100% O2 for 3 min by face mask then anesthesia will be induced with intravenous propofol 2mg/ kg ,fentanyl 1.5 µg/ kg and vecuronium bromide 0.1mg/ 32 Active-Treatment of Control Group
Experimental Group Group 2: Magnesium sulphate group (group M) each patient will receive a bolus of 25 ml (30m/kg Magnesium sulphate diluted by normal saline) followed by continuous infusion of 25mg/kg/h Magnesium sulphate Bolus doses will be given over 10 min prior to initiation of anesthesia followed by infusion till the end of the surgery .(for a maximum of 180 min Bolus doses will be given over 10 min prior to initiation of anesthesia followed by infusion till the end of the surgery .(for a maximum of 180 min to avoid lidocaine toxicity). After termination of the bolus dose, the patients will be oxygenated by 100% O2 for 3 min by face mask then anesthesia will be induced with intravenous propofol 2mg/ kg ,fentanyl 1.5 µg/ kg and vecuronium bromide 0.1mg/ 32 Active-Treatment of Control Group
Experimental Group Group 3: Dexemedetomidine group (group D) each patient will receive a bolus of 25 ml (1µg/kg Dexemedetomidine diluted by normal saline) followed by continuous infusion of 0.5µg/kg/h Dexemedetomidine Bolus doses will be given over 10 min prior to initiation of anesthesia followed by infusion till the end of the surgery .(for a maximum of 180 min Patients will be premedicated with intravenous ranitidine 0.25 mg/kg, metoclopramide 0.15 mg/kg in preoperative room. On arrival in the operation theater, monitors will be attached (heart rate, NIBP, oxygen saturation, ECG) and baseline vital parameters like heart rate, systolic and diastolic blood pressure, and oxygen saturation will be recorded Bolus doses will be given over 10 min prior to i 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
96 adult patients, aging (25-65y),(ASA I&II) of both sex presented for laparoscopic cholecystectomy surgery in Tanta University Hospital ¿ Cardiovascular instability (elderly & diabetics) ¿ Patient with chronic hypertension ¿ Sever cardiac deseases. AV block ¿ Patients on b-blockers or ca channel blockers ¿ History of allergy to local anesthetics. ¿ History of allergy to ¿2 agonist drugs . ¿ Patient with exaggerated hypertensive response (systolic<180, diastolic <110mmhg) ¿ Patients whose operation not completed laparoscopically and converted to open cholecystectomy, surgical time<180 min. ¿ Major liver or renal diseases ¿ Pregnancy ¿ Patients who received opioids or NSAIDS one week prior to surgery 25 Year(s) 65 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 01/05/2016 Tanta Univercity, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome is to compare the effects of using intraoperative dexemedetomidine, magnesium or lidocaine infusion on haemodynamic stress response to laryngoscopy , endotracheal intubation, creation of Pneumoperitoneum, and extubation in laparoscopic cholecystectomy. laryngoscopy , endotracheal intubation, creation of Pneumoperitoneum, and extubation in laparoscopic cholecystectomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hospital Elbahr Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univercity Hospital anaesthesia department Elbahr Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity hospital anaesthesia department Elbahr Street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohammed Megahed Lecturer of anesthesia and surgical Intensive care Faculty of medicine Tanta University Elmoatasem Street Tanta Egypt
Wesam Mohammed AboelazmNassar Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesiaand surgical Intensive care Faculty of medicine Tanta University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information