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Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Mansoura University
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University Identifier:
First received: January 7, 2013
Last updated: February 5, 2016
Last verified: February 2016

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
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

Resource links provided by NLM:

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Mean blood pressure [ Time Frame: Changes from baseline for 60 min after delivery ] [ Designated as safety issue: Yes ]
    Mean blood pressure

Secondary Outcome Measures:
  • 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: March 2016
Estimated Primary Completion Date: February 2016 (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


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01766089

Contact: Mohamed r El Tahan, MD 00966569371849

Mansoura University Hospitals Recruiting
Mansoura, DK, Egypt, 050
Contact: Mohamed R El Tahan, MD    00966569371849   
Sponsors and Collaborators
Mansoura University
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

Responsible Party: Mohamed R El Tahan, Associate professor, Mansoura University Identifier: NCT01766089     History of Changes
Other Study ID Numbers: R/61  R/61 
Study First Received: January 7, 2013
Last Updated: February 5, 2016
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Mansoura University:
Caesarean delivery
severe pre-eclampsia
cardiovascular response

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on January 17, 2017