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Comparison Between Dexmedetomidine and Remifentanil on the Maternal Responses to Tracheal Intubation in Severe Pre-eclamptic Patients During Caesarean Delivery
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Mansoura University, Mansoura, Egypt
interventional
50
1 country
1
Study Start
January 2013
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
January 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Actual (reported)January 7, 2013
Actual (reported)January 11, 2013
Actual (reported)December 2016
Actual (reported)January 2017
Actual (reported)Mean blood pressure
Mean blood pressure
Changes from baseline for 60 min after delivery
Systolic blood pressure
Changes from baseline for 60 min after delivery
Heart rate
Changes from baseline for 60 min after delivery
Diastolic blood pressure
Changes from baseline for 60 min after delivery
neonatal Apgar scores
from delivery to 5 minutes after that
Neurologic and adaptive capacity score
for 24 hours after delivery
dexmedetomidine intravenous infusion rate of 0.4 µg/kg/h
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.
dexmedetomidine (0.4 µg/kg/h) starting 20 before induction of anaesthesia and continued until peritoneal closure
Mansoura University Hospitals
Al Mansurah, DK, 050, Egypt
Samah El Kenany S, MD
Lecurer of Anesthesiology
Eyad A Ramzy, MD
Lecturer of Anesthesiology and Pain Management
Ehsan M Abdelaty, MD
Lecturer of Clinical Pathology
50 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2013
First Posted
January 11, 2013
Study Start
January 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
January 23, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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