Dexmedetomidine for Cesarean Delivery

NCT01005433 | Completed Phase 1

• 2 other identifiers: 10/2009+966 (56) 9371849
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant Women Undergoing Cesarean Delivery

Keywords

dexmedetomidine; stress response; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (1)

• 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

  after delivery, and postoperative

Study Arms (4)

Dexmedetomidine 0.6 µg/kg/h

ACTIVE COMPARATOR

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

Dexmedetomidine 0.4 µg/kg/h

ACTIVE COMPARATOR

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

Dexmedetomidine 0.2 µg/kg/h

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine 0.2 µg/kg/h; Dexmedetomidine 0.4 µg/kg/h; Dexmedetomidine 0.6 µg/kg/h

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal University: lead

Study Sites (1)

King Faisal University

Dammam, Eastern Province, 31952, Saudi Arabia

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed R El Tahan, M.D

  King Faisal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 26, 2012

Record last verified: 2012-03

Locations

SA (1)