Dexmedetomidine for Cesarean Section

NCT02715154 | Completed Phase 1

• 1 other identifier: JSPH-A-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research. This study intends to use of dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects on the parturients' haemodynamics and the neonates' placental transfer and metabolism.

Conditions

Cesarean Section, Affecting Fetus or Newborn

Keywords

Epidural Anaesthesia; Cesarean Section; Dexmedetomidine

Outcome Measures

Primary Outcomes (4)

• Systolic blood pressure of Dexmedetomidine in Epidural Anaesthesia

  identifying the effects of 0.5 µg/kg/h dexmedetomidine for systolic blood pressure changes.

  before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation

• Diastolic blood pressure of Dexmedetomidine in Epidural Anaesthesia

  identifying the effects of 0.5 µg/kg/h dexmedetomidine for diastolic blood pressure changes.

  before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation

• Saturation of pulse oxygen of Dexmedetomidine in Epidural Anaesthesia

  identifying the effects of 0.5 µg/kg/h dexmedetomidine for saturation of pulse oxygen changes.

  before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation

• Heart rate of Dexmedetomidine in Epidural Anaesthesia

  identifying the effects of 0.5 µg/kg/h dexmedetomidine for heart rate changes.

  before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation

Secondary Outcomes (6)

• Apgar score related to treatment

  1 and 5 minute after delivery

• Blood gas analysis

  at the delivery of the baby

• adverse events

  intraoperative and in 48 hours after surgery

• plasma concentrations of dexmedetomidine

  at the delivery of the baby

• sedation of Dexmedetomidine in Epidural

  before anesthesia, skin incision and 10min after delivery

Study Arms (2)

Dexmedetomidine 0.5 µg/kg/h

ACTIVE COMPARATOR

Solution containing 5 µg/mL of dexmedetomidine was continuously infused by 0.5 μg/kg in 10 min, followed with 0.1 ml/kg/hr continuous infusion until the closure of the abdominal.

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

The placebo group (n = 20) will pumped in the same volume of saline 0.9% as calculated by patients' weight in 10 min, then will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, until the closure of the abdominal.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

The dexmedetomidine groups (n = 20 ) will receive i.v. infusion of 0.5 μg/kg of solution containing 5 µg/mL of dexmedetomidine, at 10 min after the level of anesthesia completed. Followed with 0.1ml/kg/hr continuous infusion until the closure of the abdominal.The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.

Also known as: Dexmedetomidine Hydrochloride Injection

Dexmedetomidine 0.5 µg/kg/h

Placebo DRUG

The placebo group (n = 20) will pumped in the same volume of saline 0.9% as calculated by patients' weight in 10 min, then will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, until the closure of the abdominal. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.

Placebo

Eligibility Criteria

• Age: 23 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• cases of full-term puerperas with single baby ASA I or II, aged 23 to 41 years old, weighing 61-92 kg, without spinal canal puncture contraindication and scheduled for caesarean section under epidural anesthesia were selected for this study.

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

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Cunming Liu, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief officer

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 22, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)