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.: PACTR201704002217398 Date of Approval: 20/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Dexmedetomedine Induced Hypotensive Anesthesia on the Haemostatic Markers.
Official scientific title Effect of Dexmedetomedine Induced Hypotensive Anesthesia on the Haemostatic Markers.
Brief summary describing the background and objectives of the trial Significant blood loss during post-traumatic spinal stabilization surgery is a major anesthetic challenge that might require transfusion of whole blood or blood products(1). Decreasing bleeding is important to maintain patient¿s hemodynamic stability and improve the surgical field. In spine surgery, improving the surgical field is especially important due to the presence of major and easily traumatized neurological structures. Improving the surgical field helps the surgeon to decrease the operative time, which further decreases bleeding (2).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied spine surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Dexmedetomedine Induced Hypotensive Anesthesia
Anticipated trial start date 01/03/2017
Actual trial start date 01/04/2017
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date 02/09/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31421/03/17 research ethics commitee
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 Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group I will receive norrmotensive anesthesia from the beginning till end of surgery Anaesthesia will be induced with fentanyl 1 µgm¿kg, propofol 2 mg¿ kg, and cis-atracurium 0.2 mg¿ kg. Endotracheal intubation will be performed and mechanical ventilation will be applied. Anaesthesia will be maintained by iso-flurane 1.2 in a gas mixture of oxygen (40%) and nitrous oxide (60%). 30 Placebo
Experimental Group group II an infusion of dexmedetomidine will be made by adding 200µg (2ml) of dexmedetomidine to 48ml of normal saline, making it to a final concentration of 4µg/ml. The infusion will be then start from after induction of anesthesia till end of surgery an infusion of dexmedetomidine will be made by adding 200µg (2ml) of dexmedetomidine to 48ml of normal saline, making it to a final concentration of 4µg/ml. The infusion will be then started, with a loading dose of 1µg/kg over 10 min followed by a maintenance infusion at 0.2-0.7µg/kg/hr titrated according to the patients desired target blood pressure. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients will be included in the study if their age 18-40 and ASA I, II. Exclusion criteria comprised patients with a history of blood disease, a family history of blood disorder, renal or hepatic disease. Patients will be also informed to stop aspirin or any nonsteroidal anti-inflammatory drugs 3 weeks before the operation. 18 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 21/03/2017 research ethics committee
Ethics Committee Address
Street address City Postal code Country
faculty of medicine tanta university tanta 6666 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Induced hypotension with mean arterial blood pressure (MAP) values of 55¿65 mm Hg reduces intraoperative blood loss and thereby optimizes surgical conditions an infusion of dexmedetomidine will be made by adding 200µg (2ml) of dexmedetomidine to 48ml of normal saline, making it to a final concentration of 4µg/ml. The infusion will be then started, with a loading dose of 1µg/kg over 10 min followed by a maintenance infusion at 0.2-0.7µg/kg/hr titrated according to the patients desired target blood pressure.
Primary Outcome effect of Dexmedetomidine induced hypotensive anesthesia on platelet aggregation during surgery measure collagen platelet aggregation at 60 min, 120 min and at end of surgery.
Secondary Outcome effect of Dexmedetomidine induced hypotensive anesthesia on the other hemostatic markers 2 hours and 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals 1 el geish street tanta 11111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
anesthesia department 1 el geish street tanta 2233 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department 1 el geish street tanta 2233 Egypt Hospital
Secondary Sponsor tanta university 4 elgeish street tanta 5555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Gehan Morsy Eid 7 tharwat street tanta 1122 Egypt
Mohamed Mohye Eldin AbuElyazed 15 elestad street tanta 4444 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 tharwat street
City Postal code Country Position/Affiliation
tanta 2233 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Public Enquiries gehan eid gehan2552011@gmail.com 01287466651 7 tharwat street
City Postal code Country Position/Affiliation
tanta 2233 Egypt Lecturer of Anaesthesia and and Intesive care
Role Name Email Phone Street address
Scientific Enquiries mohamed abu elyazed moh_yazed75@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta 3344 Egypt Lecturer of Anaesthesia and and Intesive care
REPORTING
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