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.: PACTR201703002085343 Date of Approval: 09/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does spinal dexmedetomidine aggravate hypotension after tourniquet deflation?
Official scientific title Is spinal dexmedetomidine aggravating hypotension after tourniquet deflation?
Brief summary describing the background and objectives of the trial Inflation of the tourniquet applied to the extremities is of great value in optimizing operating conditions by creating a bloodless surgical field. However, Inflation of a tourniquet is followed by the development of a dull, aching pain. Such pain can accompany adequate regional anesthesia (1). Memis D et al, 2004 evaluated the effect of dexmedetomidine when added to lidocaine in IV regional anesthesia (IVRA) and concluded that tourniquet pain and total fentanyl consumption were reduced by the dexmedetomidine containing lidocaine solution (2). It has been reported, dexmedetomidine improves the quality of intrathecal and epidural anesthesia (#). Dexmedetomidine results in postsynaptic activation of central alpha 2 adrenoceptors (¿2-ARs) giving sympatholytic effect, leading to hypotension and bradycardia, an effect judiciously used to attenuate the stress response of surgery (3). Tourniquet deflation can trigger acute hypotension and, in rare instance, fatal circulatory collapse (4). So that, there is a question is raised, is intrathecal dexmedetomidine may aggravate the acute hypotension after tourniquet deflation or not?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied tourniquet hypotension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/03/2017
Actual Last follow-up date 01/03/2017
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known R/16.03.87
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 envelope Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group DBupi 15mg 2hr 15mg bupivacaine+precedex 1Ug/kg 30 Active-Treatment of Control Group
Experimental Group dexmedetomidine 15mg+dexemedetomidine 2 hr 15mg bupivacaine+dexemedetomidine 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA ¿ ¿ II. Patients scheduled for elective knee arthroscopy under spinal anesthesia ¿ Increased intracranial pressure. ¿ Hemorrhagic diathesis. ¿ Infection at the puncture site. ¿ Neurological disorder. 20 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 01/04/2016 Mansoura Faculy of medicine
Ethics Committee Address
Street address City Postal code Country
Algomhuria st Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the effect of intrathecal dexemetomedine in hemodynamics after tourniquet deflation in knee arthroscopy. 2 hours
Secondary Outcome evaluate efficacy of addition dexemetomedine in spinal anesthesia in decreasing incidence of tourniquet pain. 10 min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital Algomhuria street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Farid farida hassan Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura aculty of medicine Al Gomhuria Mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Farid farida hassan Mansoura Egypt
Mohamed Maher Beder El baz Ahmed Maher st Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Farid 01002356222fareed@gmail.com 00201002356222 fareeda hassan
City Postal code Country Position/Affiliation
Mansoura Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Farid 01002356222fareed@gmail.com 00201002356222 fareeda hassan
City Postal code Country Position/Affiliation
Mansoura Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Farid 01002356222fareed@gmail.com 0020100256222 fareeda hassan
City Postal code Country Position/Affiliation
Mansoura Egypt
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