Trial no.:
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PACTR201508001198128 |
Date of Approval:
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12/07/2015 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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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 |
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Purpose of the trial |
Treatment: Drugs |
Anticipated trial start date |
03/08/2015 |
Actual trial start date |
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Anticipated date of last follow up |
01/02/2016 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
80 |
Actual target sample size (number of participants) |
88 |
Recruitment status |
Not yet recruiting |
Publication URL |
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