Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery

This study is currently recruiting participants.
Verified January 2013 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01766089
First received: January 7, 2013
Last updated: January 9, 2013
Last verified: January 2013
  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

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: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766089

Contacts
Contact: Mohamed r El Tahan, MD 00966569371849 mohamedrefaateltahan@yahoo.com

Locations
Egypt
Mansoura University Hospitals Recruiting
Mansoura, DK, Egypt, 050
Contact: Mohamed R El Tahan, MD    00966569371849    mohamedrefaateltahan@yahoo.com   
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

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 April 20, 2014