Dexmedetomidine vs. Remifentanil for Pre-eclampsia During Caesarean Delivery

NCT01766089 | Completed Phase 2 DMC

• 1 other identifier: R/61
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Severe Pre-eclampsia

Keywords

Caesarean delivery; severe pre-eclampsia; remifentanil; dexmedetomidine; cardiovascular response

Outcome Measures

Primary Outcomes (1)

• Mean blood pressure

  Mean blood pressure

  Changes from baseline for 60 min after delivery

Secondary Outcomes (6)

• 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

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

dexmedetomidine intravenous infusion rate of 0.4 µg/kg/h

Drug: Dexmedetomidine

Remifentanil

PLACEBO COMPARATOR

remifentanil intravenous infusion rate of 0.1 µg/kg/min

Drug: Remifentanil

Interventions

Remifentanil DRUG

Remifentanil (0.1 µg/kg/min) starting 5 min before induction of anaesthesia and continued until peritoneal closure.

Remifentanil

Dexmedetomidine DRUG

dexmedetomidine (0.4 µg/kg/h) starting 20 before induction of anaesthesia and continued until peritoneal closure

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• gestational age ≥ 34 weeks
• severe pre-eclampsia
• symptoms of imminent eclampsia
• Caesarean delivery
• General anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 11, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

EG (1)