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.: PACTR201706002303170 Date of Approval: 19/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine as a Part of General Anesthesia for Cesarean Delivery in Patients with Pre-eclampsia: Efficacy and Fetal Outcome
Official scientific title Dexmedetomidine adminstration in Patients with Pre-eclampsia undergoing caeserian section
Brief summary describing the background and objectives of the trial Dexmedetomidine is highly lipophilic, because of this property, it doesn't cross the uteroplacental barrier. In addition, it increases the frequency and amplitude of uterine contraction directly. The present study used dexmedetomidine as a part of general anesthesia in patients with pre-eclampsia undergoing cesarean delivery to assess its effects on the intubation-related stress response, intraoperative hemodynamics, fetal outcome, postoperative analgesia and the correlation between the maternal and the fetal plasma level of dexmedetomidine will be determined.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,anesthesia,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Dexmedetomidine
Anticipated trial start date 06/08/2016
Actual trial start date 07/08/2016
Anticipated date of last follow up 14/05/2017
Actual Last follow-up date 14/05/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomization by computer 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 normal saline 1 microgram/kg/h 10 min before and during surgery IV adminstration 20 Placebo
Experimental Group dexmedetomidine 1 microgram/kg then 0.4 microgram/kg/h 10 min before surgery then during surgery IV adminstration 20
Experimental Group dexmedetomidine 1 microgram/kg then 0.6 microgram/kg/h 10 min before surgery then during surgery IV adminstration 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included were 18-40 years, with gestational age ¿ 34 weeks and have mild pre-eclampsia with a systolic blood pressure < 160 mm Hg and a diastolic blood pressure < 110 mmHg and urinary protein dipstick + or 2+. Exclusion criteria included patient refusal to be included in the study, allergy to dexmedetomidine, body mass index >40kg/m2, systemic diseases (cardiac, pulmonary, hepatic, renal, neurological, neuromuscular, diabetes mellitus, anemia, coagulation disorders, bleeding disorders, seizures), HELLP syndrome, patients receiving anticoagulant or antipsychotic drugs, anti-partum hemorrhage, fetal distress and multiple pregnancy. 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 03/07/2016 anesthesia department,faculty of medicine,menoufiya university
Ethics Committee Address
Street address City Postal code Country
3, yassin abd elghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean arterial blood pressure baseline before dexmedetomidine administration then 1&5 min after intubation then every 5 min till 10 min after extubation
Secondary Outcome serum cortisol before giving dexmedetomidine, before induction of general anesthesia, 1&5 min after intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufiya faculty of medicine hospital 3, yassin abd elghafar street Shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ashraf eskandr 3, yassin abd elghafar street shibin elkoom 12345 Egypt
elham elfiky 3, yassin abd elghafar street shibin elkoom 12345 Egypt
islam eldosoky 3, yassin abd elghafar street shibin elkoom 12345 Egypt
abdel rahman ahmed 3, yassin abd elghafar street shibin elkoom 12345 Egypt
ahmed abdel raouf 3, yassin abd elghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt assistant professor,menoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries abdel rahman ahmed ameskandr@yahoo.com 00201223312987 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt assistant professor,menoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries islam eldosoky ameskandr@yahoo.com 00201005768306 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12345 Egypt assistant lecturer,menoufiya faculty of medicine
REPORTING
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