Dexmedetomidine for Cesarean Delivery
This study has been completed.
Sponsor:
King Faisal University
Information provided by:
King Faisal University
ClinicalTrials.gov Identifier:
NCT01005433
First received: October 30, 2009
Last updated: March 22, 2012
Last verified: March 2012
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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.
|
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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 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 May 22, 2013