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.: PACTR201602001481308 Date of Approval: 22/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Magnesium Sulfate as adjunct during anesthesia for Laparoscopic Colectomy
Official scientific title Dexmedetomidine versus Magnesium Sulfate as adjunct during anesthesia for Laparoscopic Colectomy
Brief summary describing the background and objectives of the trial We aimed to evaluate hemodynamic changes during laparoscopic colectomy and the impact of intraoperative dexmedetomidine and magnesium on these changes
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/01/2010
Actual trial start date 11/01/2010
Anticipated date of last follow up 22/08/2013
Actual Last follow-up date 22/08/2013
Anticipated target sample size (number of participants) 51
Actual target sample size (number of participants) 51
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
Parallel: different groups receive different interventions at same time during study Randomised computer generated numbers sealed opaque envelope Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine dexmedetomidine 1 µg /kg loading then maintenance (0.4 µg/kg/hr) during operative time dexmedetomidine 1 µg /kg loading then maintenance (0.4 µg/kg/hr) 17
Experimental Group magnesium sulphate MgSO4, 2g loading then maintenance (15 ¿g/kg/min) during operative time MgSO4, 2g loading then maintenance (15 ¿g/kg/min) 17
Control Group normal saline infusion 10 ml/kg/h during operative time normal saline infusion during operative time 17 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-adult patients -assigned for laparoscopic colorectal resection. -Patients required preoperative neoadjuvant therapy, -inoperable lesion requiring relieving or dysfunctioning colostomy. -Patients with cardiopulmonary diseases, renal or liver impairment or allergy to any of the used drugs. -Morbidly obese with body mass index (BMI) >35 kg/m2 were not enrolled in the study. 21 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 02/01/2010 research and ethics committee of department of anesthesia, faculty of medicine, cairo university
Ethics Committee Address
Street address City Postal code Country
1 saray street, almanial cairo 11932 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hemodynamic changes (T0): Baseline (T1): 1-min after intubation (T2): before and 5-min after peritoneal insufflation (T3 & T4), before and 5-min after tilting the table to 30o Trendelenburg position (T5 & 6), 5-min after resuming flat position (T7), 5-min after peritoneal deflation (T8), after extubation (T9) and at time of admission to PACU (T10).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo university hospital 1 saray street, almanial, cairo cairo 11932 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine-Cairo University 1 saray street, almanial, cairo cairo 11932 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine-Cairo University 1 saray street, almanial, cairo cairo 11932 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed mohamed abdelhaq 1 saray street, almanial, cairo cairo 11932 Egypt
pierre zarif 1 saray street, almanial, cairo, department of anesthesia, faculty of medicine cairo 11932 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator pierre zarif pierre_zarif@hotmail.com 00201223647115 1 saray street, almanial, cairo, department of anesthesia, faculty of medicine
City Postal code Country Position/Affiliation
cairo 11562 Egypt lecturer of anesthesiology, faculty of medicine, Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Abdelhaq mohamedabdelhaq76@hotmail.com 00201000053764 1 saray street, almanial, cairo, department of anesthesia, faculty of medicine
City Postal code Country Position/Affiliation
cairo 11932 Egypt lecturer of anesthesiology, faculty of medicine, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abdelaal Mahmoud carnitin7@yahoo.com +201113308866 39 mousa ebn nousir street
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
REPORTING
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