Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery
|ClinicalTrials.gov Identifier: NCT01766089|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : January 23, 2017
Preeclampsia is a pregnancy-specific, multisystem disorder that complicates approximately 5 % of pregnancies.
Tracheal intubation in the women with severe pre-eclampsia is usually associated with exaggerated transient increases in blood pressure, heart rate and maternal plasma catecholamine concentrations. These changes may lead to maternal cerebral oedema, haemorrhage, left ventricular failure, pulmonary oedema or mortality, and reduce uterine blood flow which may adversely affect the neonatal wellbeing. Therefore, the attenuation of the haemodynamic responses to tracheal intubation in this unique group of patients is demanding for the best of both mother and foetus.
The use of single remifentanil boluses of 0.5 to 1 µg/kg reduces effectively the haemodynamic and catecholamine responses to laryngoscopy and tracheal intubation in severe pre-eclamptics during Cesarean delivery under general anesthesia. Unfortunately, the use of 1 µg/kg doses are associated with more maternal hypotension and neonatal respiratory depression requiring resuscitation. Moreover, the use of preinduction remifentanil bolus of 0.5 µg/kg followed by a continuous infusion at 0.15-0.2 µg/kg/min is associated with significant attenuation of the maternal stress response to tracheal intubation with variable degree of neonatal depression in non-pre-eclamptic women. Whereas, the use of infusion rates of 0.1 µg/kg/min or less is less likely to produce neonatal depression.
In our previous study, we demonstrated that the preoperative administration of dexmedetomidine 0.4 and 0.6 µg/kg/h, a specific alpha 2-adrenoceptor agonist, blunts the maternal haemodynamic and hormonal responses to Caesarean delivery under sevoflurane anaesthesia without adverse neonatal effects. However the use of 0.6 µg/kg/h doses is associated with higher postoperative sedation scores.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Severe Pre-eclampsia||Drug: Remifentanil Drug: Dexmedetomidine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison Between Dexmedetomidine and Remifentanil on the Maternal Responses to Tracheal Intubation in Severe Pre-eclamptic Patients During Caesarean Delivery|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
U.S. FDA Resources
Active Comparator: Dexmedetomidine
dexmedetomidine intravenous infusion rate of 0.4 µg/kg/h
dexmedetomidine (0.4 µg/kg/h) starting 20 before induction of anaesthesia and continued until peritoneal closure
Placebo Comparator: Remifentanil
remifentanil intravenous infusion rate of 0.1 µg/kg/min
Remifentanil (0.1 µg/kg/min) starting 5 min before induction of anaesthesia and continued until peritoneal closure.
- Mean blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ]Mean blood pressure
- Systolic blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ]Systolic blood pressure
- Heart rate [ Time Frame: Changes from baseline for 60 min after delivery ]Heart rate
- Diastolic blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ]Diastolic blood pressure
- neonatal Apgar scores [ Time Frame: from delivery to 5 minutes after that ]Apgar scores
- Neurologic and adaptive capacity score [ Time Frame: for 24 hours after delivery ]Neonatal neurologic and adaptive capacity score (NACS)
- Maternal Cortisol [ Time Frame: from baseline for 1 hour after delivery ]Plasma cortisol level
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766089
|Mansoura University Hospitals|
|Mansoura, DK, Egypt, 050|
|Study Chair:||Samah El Kenany S, MD||Lecurer of Anesthesiology|
|Study Chair:||Eyad A Ramzy, MD||Lecturer of Anesthesiology and Pain Management|
|Study Chair:||Ehsan M Abdelaty, MD||Lecturer of Clinical Pathology|