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Dexmedetomidine for Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715154
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Cunming Liu, The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section, Affecting Fetus or Newborn Drug: Dexmedetomidine Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect and Placental Transfer of Dexmedetomidine During Caesarean Section Under Epidural Anaesthesia
Study Start Date : June 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Dexmedetomidine 0.5 µg/kg/h
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
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.
Other Name: Dexmedetomidine Hydrochloride Injection

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Systolic blood pressure of Dexmedetomidine in Epidural Anaesthesia [ Time Frame: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for systolic blood pressure changes.

  2. Diastolic blood pressure of Dexmedetomidine in Epidural Anaesthesia [ Time Frame: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for diastolic blood pressure changes.

  3. Saturation of pulse oxygen of Dexmedetomidine in Epidural Anaesthesia [ Time Frame: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for saturation of pulse oxygen changes.

  4. Heart rate of Dexmedetomidine in Epidural Anaesthesia [ Time Frame: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for heart rate changes.


Secondary Outcome Measures :
  1. Apgar score related to treatment [ Time Frame: 1 and 5 minute after delivery ]
    Apgar score:The Apgar scores were evaluated at 1 and 5 minute after the delivery.

  2. Blood gas analysis [ Time Frame: at the delivery of the baby ]
    The difference of blood gas analysis from MV, UA , UV.

  3. adverse events [ Time Frame: intraoperative and in 48 hours after surgery ]
    Major complications (respiratory, cardiovascular events, nausea, vomiting and other adverse reactions)

  4. plasma concentrations of dexmedetomidine [ Time Frame: at the delivery of the baby ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for the plasma dexmedetomidine concentrations (CUV, CUA and CMV).

  5. sedation of Dexmedetomidine in Epidural [ Time Frame: before anesthesia, skin incision and 10min after delivery ]
    identifying the effects of 0.5 µg/kg/h dexmedetomidine for Ramsay sedation scales.(Ramsay standard for evaluation: 1 point: anxious or restless or both; 2 point: cooperative, orientated and tranquil; 3 point: responding to commands; 4 point: brisk response to stimulus; 5 point: sluggish response to stimulus; 6 point: no response to stimulus.)

  6. Placental Transfer of Dexmedetomidine in Epidural [ Time Frame: at the delivery of the baby ]

    identifying the effects of 0.5 µg/kg/h dexmedetomidine for the rate of placental transfer of dexmedetomidine(CUV/CMV).

    Methods:

    When the baby was born, we double clamped the umbilical cord,and extracted 3ml blood from the maternal vein(MV) on the no venous route hand, umbilical artery(UA) and umbilical vein(UV) from the isolated placenta. The blood blood from Dex group were injected heparin sodium anticoagulant tube, centrifuged 3500 revolutions per minute for 5 minutes and separated of plasma to -20℃ frozen preservation. High-performance liquid chromatography-mass spectrometry(HPLC-MS/MS) was then used for measuring the plasma dexmedetomidine concentrations (CUV, CUA and CMV). The rate of placental transfer of dexmedetomidine is CUV/CMV.




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Ages Eligible for Study:   23 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715154


Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Principal Investigator: Cunming Liu, MD The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: Cunming Liu, Chief officer, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02715154    
Other Study ID Numbers: JSPH-A-1
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cunming Liu, The First Affiliated Hospital with Nanjing Medical University:
Epidural Anaesthesia
Cesarean Section
Dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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