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.: PACTR201209000409253 Date of Registration: 04/09/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 anesthesia in caesarean section
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2012
Actual trial start date
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
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,Outcome Assessors,Participants
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-Treatment of Control Group
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 Age Category Minimum age Maximum age Gender
ASA I, II Elective c-section Non-elective c-section 18 Year(s) 40 Year(s) 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 10/08/2012 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 Street address
Principal Investigator Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt
Role Name Email Phone Street address
Public Enquiries Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Profressor
Role Name Email Phone Street address
Scientific Enquiries Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem Street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Profressor
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