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Dexmedetomidine for Cesarean Section

NCT02715154 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-28

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Cunming Liu, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715154 on ClinicalTrials.gov