Dexmedetomidine for Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by:
King Faisal University
ClinicalTrials.gov Identifier:
NCT01005433
First received: October 30, 2009
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

Regional anesthesia has become the anesthetic of choice for cesarean section in most countries; however, some women still prefer general anesthesia techniques. There are many trials for the pharmacological modifications of the sympathetic response to surgery, including opioids, tenoxicam, ketorolac, lidocaine and paracetamol. However, opioid administration to the mother before delivery has adverse neonatal effects. This research is a novel trial on the use of dexmedetomidine for suppression of the hemodynamic and hormonal responses of cesarean delivery.


Condition Intervention Phase
Pregnant Women Undergoing Cesarean Delivery
Drug: Dexmedetomidine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Dose - Dependent Study of Dexmedetomidine in Suppressing Cardiovascular and Hormonal Responses for Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by King Faisal University:

Primary Outcome Measures:
  • identifying the effects of 0.2, 0.4 and 0.6 µg/kg/h dexmedetomidine for on 1. Hemodynamic [heart rate, systolic and mean blood pressure] changes. 2. The perioperative changes in plasma cortisol and catecholamines concentrations [ Time Frame: before and 15 min after infusion; each 1 min for 10 min after induction; 15 and 30 min after delivery; and 0, 1, 5, 15, 30, and 60 min after extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Apgar score, the neurologic and adaptive capacity score (NACS), and umbilical cord venous and arterial blood gases analyses.The quality of extubation and analgesia.major complications (respiratory, cardiovascular events, and neonatal adverse outcome [ Time Frame: after delivery, and postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine 0.6 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia
Drug: Dexmedetomidine
The dexmedetomidine groups (n = 20 for each) will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2, 4, and 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure, when their infusion rate will be decreased by 50% until 20 min after extubation.
Active Comparator: Dexmedetomidine 0.4 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 4 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia
Drug: Dexmedetomidine
The dexmedetomidine groups (n = 20 for each) will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2, 4, and 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure, when their infusion rate will be decreased by 50% until 20 min after extubation.
Active Comparator: Dexmedetomidine 0.2 µg/kg/h
The dexmedetomidine group will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia.
Drug: Dexmedetomidine
The dexmedetomidine groups (n = 20 for each) will receive i.v. infusion of 0.1 mL/kg/h of solution containing 2, 4, and 6 µg/mL of dexmedetomidine, at 20 min before induction of anesthesia. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure, when their infusion rate will be decreased by 50% until 20 min after extubation.
Placebo Comparator: Placebo
The placebo group (n = 20) will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, at 20 min before induction of anesthesia
Drug: Placebo
The placebo group (n = 20) will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, at 30 min before induction of anesthesia. The placebo solution will be looked identical and their infusions will be continued until skin closure, when the infusion rate will be decreased by 50% until 20 min after extubation. The test solution will be prepared by one anesthesiologist before induction of anesthesia.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 80 women aged 18-45 years (ASA physical status II-III)with uncomplicated, singleton pregnancies of at least 36 weeks' gestation scheduled for elective cesarean delivery under general anesthesia.

Exclusion Criteria:

  • women with a history of cardiac, liver, or kidney diseases;
  • women with allergy to amide local anesthetics;
  • women with epilepsy;
  • those taking cardiovascular medications;
  • those with pregnancy-induced hypertension;
  • women with evidence of intrauterine growth restriction or fetal compromise.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005433

Locations
Saudi Arabia
King Faisal University
Dammam, Eastern, Saudi Arabia, 31952
Sponsors and Collaborators
King Faisal University
Investigators
Principal Investigator: Mohamed R El Tahan, M.D King Faisal University
  More Information

No publications provided

Responsible Party: Dr. Mohamed R. El-Tahan, King Faisal University
ClinicalTrials.gov Identifier: NCT01005433     History of Changes
Other Study ID Numbers: 10/2009, +966 (56) 9371849
Study First Received: October 30, 2009
Last Updated: March 22, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by King Faisal University:
dexmedetomidine
stress response
cesarean delivery

Additional relevant MeSH terms:
Dexmedetomidine
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

ClinicalTrials.gov processed this record on April 21, 2014