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.: PACTR201606001621312 Date of Approval: 07/05/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Blood Coagulation and Platelets Aggregation Changes in Patients Undergoing Spine Surgery: Effect of Induced hypotensive anesthesia.
Official scientific title Blood Coagulation and Platelets Aggregation Changes in Patients Undergoing Spine Surgery: Effect of Induced hypotensive anesthesia.
Brief summary describing the background and objectives of the trial Blood Coagulation and Platelets Aggregation Changes in Patients Undergoing Spine Surgery: Effect of Induced hypotensive anesthesia. Controlled (deliberate/induced) hypotension is a technique where in the arterial blood pressure is lowered in a deliberate but controllable manner to minimize surgical blood loss and enhance the operative field visibility(3). Induced hypotension with mean arterial blood pressure (MAP) values of 55¿65 mm Hg reduces intraoperative blood loss and thereby optimizes surgical conditions(8). The aim of this study is to evaluate to evaluate the effect of hypotensive anesthesia with Dexmedetomidine infusion on platelets aggregation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,spine fracure and spine disease,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/04/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date 01/10/2016
Anticipated target sample size (number of participants) 92
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
30858l04l16 research ethics committee ,faculty of medicine, tanta university
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a randomisation 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) Patients of this group will receive isoflurane maintained normotensive anesthesia. 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 to keep end-tidal CO2 between 35-40 mmHg. Anaesthesia will be maintained by iso -flurane 1.2% in a gas mixture of oxygen (40%) and air (60%). 30 Placebo
Experimental Group group (II) Patients of this group will receive hypotensive anesthesia by increasing the fractional inspired concentration of isoflurane will be ended before closure of skin incision Hypotensive agents will be started after positing of the patient in prone position and before skin incision. 30 Active-Treatment of Control Group
Experimental Group group III will receive hypotensive anesthesia with dexmetotomedine till end of surgery In Group (III), 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 18-50 and ASA I, II and enrolled for spine surgery. Exclusion criteria comprised patients with a history of blood disease, a family history of blood disorder, renal or hepatic disease, cardiac diseases and pregnant ladies. Patients will be also informed to stop aspirin or any nonsteroidal anti-inflammatory drugs 2 weeks before the operation 18 Year(s) 50 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 20/04/2016 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
faculty of medicine tanta university tanta 5555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of Dexmedetomidine induced hypotensive group on blood coagulation and platelets agregation 24 hours postoperatively
Primary Outcome effect of Dexmedetomidine induced hypotensive group on blood coagulation and platelets agregation . Blood samples for the assessement of platelets count, prothrombine time and activated partial thromboplastin time, fibrinogen and D-dimer will be taken before induction of anesthesia and 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals elgeish street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine tanta university el geish street tanta 1234 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor tanta university sedky street tanta 6666 Egypt University
COLLABORATORS
Name Street address City Postal code Country
gehan morsy eid 7 thrwat tanta 1147 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gehan eid gehan2552011@gmail.com 01287466651 7 thrwat street
City Postal code Country Position/Affiliation
tanta 1147 Equatorial Guinea lecturer of anesthesiology faculty of medicine tanta university
Role Name Email Phone Street address
Public Enquiries mohammed abo el yazed mohd_yazed75@yahoo.com 01120014472 15 elestad street
City Postal code Country Position/Affiliation
tanta 6666 Egypt lecturer of anesthesiology faculty of medicine tanta university
Role Name Email Phone Street address
Scientific Enquiries gehan eid gehan2552011@gmail.com 01287466651 7 thrwat street
City Postal code Country Position/Affiliation
tanta 1147 Egypt lecturer of anesthesiology faculty of medicine tanta university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information