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Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766089
First Posted: January 11, 2013
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Mohamed R El Tahan, Mansoura University:

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


Secondary Outcome Measures:
  • 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


Enrollment: 50
Actual Study Start Date: January 2013
Study Completion Date: January 2017
Primary Completion Date: December 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

  Eligibility

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766089


Locations
Egypt
Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
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
ClinicalTrials.gov Identifier: NCT01766089     History of Changes
Other Study ID Numbers: R/61
R/61 ( Other Grant/Funding Number: Mansoura University, Mansoura, Egypt )
First Submitted: January 7, 2013
First Posted: January 11, 2013
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Mohamed R El Tahan, 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
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
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics