Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pregnancy Severe Pre-eclampsia |
Drug: Remifentanil Drug: Dexmedetomidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Comparison Between Dexmedetomidine and Remifentanil on the Maternal Responses to Tracheal Intubation in Severe Pre-eclamptic Patients During Caesarean Delivery |
- Mean blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ] [ Designated as safety issue: Yes ]Mean blood pressure
- Systolic blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ] [ Designated as safety issue: Yes ]Systolic blood pressure
- Heart rate [ Time Frame: Changes from baseline for 60 min after delivery ] [ Designated as safety issue: Yes ]Heart rate
- Diastolic blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ] [ Designated as safety issue: Yes ]Diastolic blood pressure
- neonatal Apgar scores [ Time Frame: from delivery to 5 minutes after that ] [ Designated as safety issue: Yes ]Apgar scores
- Neurologic and adaptive capacity score [ Time Frame: for 24 hours after delivery ] [ Designated as safety issue: Yes ]Neonatal neurologic and adaptive capacity score (NACS)
- Maternal Cortisol [ Time Frame: from baseline for 1 hour after delivery ] [ Designated as safety issue: No ]Plasma cortisol level
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexmedetomidine
dexmedetomidine intravenous infusion rate of 0.4 µg/kg/h
|
Drug: Dexmedetomidine
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
|
Drug: Remifentanil
Remifentanil (0.1 µg/kg/min) starting 5 min before induction of anaesthesia and continued until peritoneal closure.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- gestational age ≥ 34 weeks
- severe pre-eclampsia
- symptoms of imminent eclampsia
- Caesarean delivery
- General anaesthesia
Exclusion Criteria:
- allergy to dexmedetomidine
- cardiac disease
- pulmonary disease
- hepatic disease
- renal disease
- neurological disease
- neuromuscular disease
- body mass index >35kg/m2
- diabetes mellitus
- anemia
- coagulation disorders
- bleeding disorders
- seizures
- Hemolysis, Elevated Liver enzymes and Low platelet count (HELLP) syndrome
- receiving cardiovascular medications
- receiving antipsychotic medications
- receiving hypnotic medications
- alcoholic
- drug abuse
- foetal distress
- placenta praevia
- abruptio placenta
- multiple pregnancy
Contacts and Locations| Contact: Mohamed r El Tahan, MD | 00966569371849 | mohamedrefaateltahan@yahoo.com |
| Egypt | |
| Mansoura University Hospitals | Recruiting |
| Mansoura, DK, Egypt, 050 | |
| Contact: Mohamed R El Tahan, MD 00966569371849 mohamedrefaateltahan@yahoo.com | |
| 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 |
More Information
No publications provided
| Responsible Party: | Mohamed R El Tahan, Associate professor, Mansoura University |
| ClinicalTrials.gov Identifier: | NCT01766089 History of Changes |
| Other Study ID Numbers: | R/61, R/61 |
| Study First Received: | January 7, 2013 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Egypt: Ministry of Higher Education |
Keywords provided by Mansoura University:
|
Caesarean delivery severe pre-eclampsia remifentanil dexmedetomidine cardiovascular response |
Additional relevant MeSH terms:
|
Eclampsia Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Dexmedetomidine Remifentanil Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013