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.: PACTR201508001198128 Date of Approval: 12/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine versus Fentanyl on Intubation Stress Responses in Pre-eclamptic patients undergoing Caesarean delivery.
Official scientific title Intubation Stress Responses: pre-anesthetic Dexmedetomidine versus Fentanyl in Pre-eclamptic patients undergoing Caesarean delivery.
Brief summary describing the background and objectives of the trial Laryngoscopy and intubation are associated with cardiovascular changes such as hypertension, tachycardia, dysrhythmias and even, myocardial ischemia and increased circulating catecholamines.Several techniques have been proposed to prevent or attenuate the hemodynamic responses following laryngoscopy and intubation, such as deepening of anaesthesia,pre-treatment with vasodilators (such as nitroglycerin, beta-blockers, calcium channel blockers and opioids. In women with pregnancy-induced hypertension, the cardiovascular response to tracheal intubation is exaggerated.The abrupt increase in arterial pressure, although transient, can lead to cerebral oedema and haemorrhage, and cardiac failure with pulmonary oedema, increasing morbidity and mortality in both the mother and child. an increase in maternal plasma catecholamine concentrations at the induction of anaesthesia for Caesarean delivery can cause uteroplacental vasoconstriction and hence adversely affect the neonate. Hence close control of stress responses during induction of anaesthesia for Caesarean delivery can have both fetal and maternal benefits in pre-eclamptic patients. Dexmedetomidine is a highly selective adrenoreceptor agonist, used as adjunctive anesthetic agent because of its hypnotic, sedative, anxiolytic, sympatholytic, and analgesic properties without producing significant respiratory depression. A section of pre-eclamptic patients do caesarean delivery under general anesthesia for several reasons, for these patients we hypothesized that the sympatholytic effects of dexmedetomidine may blunt the hemodynamic exaggerated response to tracheal intubation as a safe and effective substitute for fentanyl. The present study design as randomized controlled trial to evaluate the effects of dexmedetomidine and fentanyl on the changes in blood pressure and heart rate observed during laryngoscopy and tracheal intubation in pre-eclamptic patients, as a primary goal and the neonatal outcome as a second goal.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied pre- eclampsia, caesarean delivery,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/08/2015
Actual trial start date
Anticipated date of last follow up 01/02/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 88
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Research Ethics Committee, Tanta University, Facualty of Medicine Approval code: 30139/03/31
Research Ethics Committee, Tanta University, Facualty of Medicine Approval code: 30139/03/31
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly allocated into two groups by using sealed opaque envelope technique; the envelope will be opened by another investigator who had no subsequent role in the study. Group F (Fentanyl group) and group D (Dexmedetomidine group) 44 patients in each. sealed opaque envelope technique Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine infusion 0.5 ug/kg preemptive dexmedetomidine 0.5 ug/kg prepared in 10 ml of 0.9% saline solution 44
Control Group Fentanyl 1 ug/kg preemptive Fentanyl 1 ug/kg prepared in 10 ml of 0.9% saline solution 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women aged ¿ 18 years, with severe pre-eclampsia undergoing elective caesarean deliveries will be enrolled. Pre-eclampsia will be regarded as severe {if the systolic arterial pressure (SAP) on admission exceed 160 mm Hg, the diastolic pressure exceed 110 mm Hg, or both, obtained on at least two separate occasions, or if the patient has symptoms of imminent eclampsia (severe headache, visual disturbance, epigastric pain, hyper-reflexia, or vomiting), and proteinuria on urine dipstick was 3+ or worse}. suspected difficult intubation (mallanpati score 3-4), history of exacerbated chronic medical disease, diabetes mellitus, morbid obesity, allergy to drugs used, and known fetal anomalies. Patients will be excluded from analysis if tracheal intubation takes longer than 40 seconds or if more than 1 attempt will be required for successful intubation. 18 Year(s) 45 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 23/03/2015 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El-Geish st Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate the effects of dexmedetomidine and fentanyl on the changes in blood pressure and heart rate observed during laryngoscopy and tracheal intubation in pre-eclamptic patients 1-Demographic data, 2- Systolic arterial pressure (SAP) ,diastolic arterial pressure (DAP) and HR will be recorded by an independent investigator before injection of the study drug (baseline), just before initiating laryngoscopy and tracheal intubation (time 0), and at 1 min intervals up to 5 min thereafter.
Secondary Outcome neonatal outcome 1- Apgar score to assess at 1, 5 and 10 min after delivery, 2- the time to sustained respiration. 3- The need for ventilator assistance and intensive care unit admission will be recorded.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital, Facualty of Medicine El-Geish st Tanta / Gharbia 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The Researchers supported this work fund. Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rehab Said Elkalla El-Geish st Tanta / Gharbia 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammad A. Abdullah El-Geish st Tanta / Gharbia 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
Role Name Email Phone Street address
Principal Investigator Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mohammad Abdullah moh_aly_2005@hotmail.com +201099957971 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mohammad Abdullah moh_aly_2005@hotmail.com +201099957971 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Rehab ElKalla rehouba10@hotmail.com +201285700765 El-Geish st
City Postal code Country Position/Affiliation
Tanta/ Gharbia 31257 Egypt Lecturer of anesthesiology and surgical intensive care
REPORTING
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