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.: PACTR201801003001727 Date of Approval: 23/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between intrathecal dexmedetomidine versus intrathecal magnesium sulfate in prevention of post spinal shivering in uroscopic surger
Official scientific title Comparative study between intrathecal dexmedetomidine versus intrathecal magnesium sulfate in prevention of post spinal shivering in uroscopic surgery
Brief summary describing the background and objectives of the trial spinal anesthesia is known to significantly impair thermoregulation and predispose patients to hypothermia and shivering. This study aims to evaluate and compare the effect of intrathecal dexmedetomidine versus intrathecal magnesium sulfate in prevention of post spinal shivering in patients undergoing uroscopic surgery which associated fluid irrigation and hypothermia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post spinal shivering,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 04/09/2017
Actual trial start date 14/09/2017
Anticipated date of last follow up 22/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
Recruitment status Completed
Publication URL Comparative study between intrathecal dexmedetomidine versus intrathecal magnesium sulfate in prevention of post spinal shivering in uroscopic surgery
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal saline 0.5 ml once intrathecal injection 35 Placebo
Experimental Group magnesium sulfate 25 mg once intrathecal injection 35
Experimental Group dexmedetomidine 5 mic once intrathecal injection 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Uroscopic surgeries. 2) ASA I and II. 3) Age 20-60years old. 1) Patient refusal. 2) Contraindication to spinal anesthesia e.g; coagulopathy. 3) ASA III- IV. 4) Neurological diseases e.g.; Parkinson¿s disease, Dysautonomia. 5) Endocrine diseases except diabetes mellitus. 20 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 20/10/2015 anesthetic department ethical commitee
Ethics Committee Address
Street address City Postal code Country
Kase Eini street
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence and intensity of shivering percentage grade
Secondary Outcome 1) Use of pethidine in case of occurrences of shivering. number and percentage
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kasr Eini hospital kasr Eini street Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr Eini hospital, faculty of medicine, Cairo university Kasr Eini street Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr Eini hospital, faculty of medicine, Cairo university Kasr Eini street Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Heba Omar Hadaek Elahram Cairo 12572 Egypt
Wessam Adel Hadaek Elahram Cairo 12572 Egypt
Mai Wedad Dokki Cairo 12611 Egypt
Mona Hossam Kasr Eini street Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Omar hebaomar2@yahoo.com 01128102222 Hadayek Elahram
City Postal code Country Position/Affiliation
Cairo 12572 Egypt lecturer of anesthesia, faculty of medicine, Cairo university
Role Name Email Phone Street address
Public Enquiries Heba Omar hebaomar2@yahoo.com 01128102222 Hadayek Elahram
City Postal code Country Position/Affiliation
Cairo 12572 Egypt lecturer of anesthesia, faculty of medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Heba Omar hebaomar2@yahoo.com 01128102222 Hadayek Elahram
City Postal code Country Position/Affiliation
Cairo 12572 Egypt lecturer of anesthesia, faculty of medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Wessam Adel wessamadel782@gmail.com 01001237851 Hadayek Elahram
City Postal code Country Position/Affiliation
Cairo 12572 Egypt Assistant lecturer of anesthesia, Elsahel hospital
Role Name Email Phone Street address
Scientific Enquiries Mai wedad mai.wedad@kasralainy.edu.eg 01228978904 Dokki
City Postal code Country Position/Affiliation
Cairo 12611 Egypt professor of anesthesia, faculty of medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Mona Hossam monahossam29@yahoo.com 0114034061 kasr eini
City Postal code Country Position/Affiliation
Cairo 11652 Egypt Associate professor of anesthesia, faculty of medicine, Cairo 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