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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: www.pactr.org

Trial no.: PACTR201209000409253 Date registered: 2012/09/04
TRIAL DESCRIPTION
Public title Role of epidural dexmedetomidine in elective caesarean section
Official scientific title The effect of small dose epidural demedetomidine in elective caesarean section using combined spinal-epidural anesthesia
Brief summary describing the background
and objectives of the trial
The combined spinal¿epidural anesthesia is being commonly used for elective caesarean section. Intrathecal injection produces a rapid onset with minimal doses of local anesthetic while the epidural administration can be used to prolong the block using varies additives. Our study examined the effect of adding dexmedetomidine to epidural bupivacaine and fentanyl in patients undergoing elective caesarean section using combined spinal¿epidural anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2012-10-01
Actual trial start date
Anticipated date of last follow up 2012-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 80   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Bupivacaine /Fentanyl 1.5mL intra-thecal 0.5% hyperbaric bupivacaine, 10mL epidural 0.25% plain bupivacaine with fentanyl 50 µg, and 4mL of epidural 0.9% sodium chloride once 1.5mL intra-thecal 0.5% hyperbaric bupivacaine, 10mL epidural 0.25% plain bupivacaine with fentanyl 50 µg, and 4mL of epidural 0.9% sodium chloride 40 Active
Experimental group Dexametamodine 1.5mL intrathecal 0.5% hyperbaric bupivacaine, 10mL epidural 0.25% plain bupivacaine with fentanyl 50 µg, and 4mL epidural dexametamodine contain 0.5 µg/kg. once 1.5mL intrathecal 0.5% hyperbaric bupivacaine, 10mL epidural 0.25% plain bupivacaine with fentanyl 50 µg, and 4mL epidural dexametamodine contain 0.5 µg/kg. 40

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
ASA I, II Elective c-section Non-elective c-section 18 Years 40 Years Female

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 2012/08/10 Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
El guish street Tanta Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Motor and sensory block every 3 minutes for 30 minutes
Secondary Outcome visual analogue scale every 15 minutes for four hours
Secondary Outcome sedation score every 15 minutes for four hours

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine, Tanta University El guish street Tanta Egypt Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
University of Tanta El guish street Tanta Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Tanta University Alguish street Tanta Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Hesham Abdelaziz salem Gynecology Dept., Faculty of Medicine, Tanta Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403327747
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem Street Tanta Egypt
Role Name Email Phone Fax
Public Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403327747
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem Street Tanta Egypt Assistant Profressor
Role Name Email Phone Fax
Scientific Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403327747
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem Street Tanta Egypt Assistant Profressor