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Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

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ClinicalTrials.gov Identifier: NCT02532270
Recruitment Status : Unknown
Verified November 2015 by Chao Han, Fudan University.
Recruitment status was:  Recruiting
First Posted : August 25, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Chao Han, Fudan University

Brief Summary:
The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .

Condition or disease Intervention/treatment Phase
Hypotension Drug: phenylephrine Not Applicable

Detailed Description:

Peri-operative hypotension and fluctuation of arterial blood pressure (BP) during spinal anaesthesia are common. Hypotension causes maternal side-effects such as unconsciousness, dizziness, nausea, and vomiting. The potential fetal side-effects are caused by a reduction in the uterine blood flow with consequent reduced oxygen supply and acidosis reflected by impaired blood gas analyses and impaired Apgar scores. Because of the potential harm to the fetus and the dependency of fetal oxygenation on maternal arterial pressure (AP), it has been strongly recommended to closely monitor mother's arterial pressure and to treat hypotension immediately. Non-invasive arterial pressure (NIAP) measurement is a common method for monitoring in clinical. These hypotension episodes probably would be detected with delay by NIAP measurement on account of its discontinuous. A monitor for continuous non-invasive arterial pressure monitoring (CNAPTM Monitor 500, CNSystems Medizintechnik AG,Graz, Austria) using the volume-clamped method. It can monitor timely and provide beat-to-beat value of arterial pressure.

The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring During Spinal Anaesthesia for Cesarean Section:A Prospective,Randomized, Controlled Study
Study Start Date : September 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group C
Arterial pressure of the patients in Group C is measured by continuous non-invasive arterial pressure (CNAP).When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug .If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
Drug: phenylephrine
When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug in Group C and Group N.If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
Other Name: Phenylephrine Hydrochloride

Experimental: Group N
Arterial pressure of the patients in Group N is measured by intermittent oscillometric non-invasive arterial pressure (NIAP).When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug .If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
Drug: phenylephrine
When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug in Group C and Group N.If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
Other Name: Phenylephrine Hydrochloride




Primary Outcome Measures :
  1. the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    (baseline SBP-minimum SBP)/baseline SBP


Secondary Outcome Measures :
  1. Detecting the occurrence of hypotension [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    systolic blood pressure decreased by over 20% of the baseline or systolic blood pressure lower than 100mmHg

  2. Neonatal outcome was assessed with Apgar scores [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
  3. umbilical cord blood gases analysis at birth [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
  4. the incidence of nausea and vomiting on account of hypotension [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    The presence of nausea and vomiting was measured on a 3-point scale of 1,2, and 3 indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively. Assessments were done at 1-minute intervals after the spinal injection until 25 min.

  5. the incidence of dizziness on account of hypotension [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    assessment:yes=patient had dizziness,no=patient had no dizziness

  6. the incidence of dyspnea on account of hypotension [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    assessment:yes=patient had dyspnea,no=patient had no dyspnea



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for elective caesarean section with spinal anaesthesia
  • pregnancy week above 36

Exclusion Criteria:

  • age<18 yr
  • cardiac arrhythmia
  • vascular pathologies of the upper limbs (recent vascular surgery, Raynaud's disease, vascular stenosis)
  • contraindication for spinal anaesthesia
  • emergency case

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): NCT02532270


Contacts
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Contact: Han +86 021-33189900-6868 webchao628@163.com

Locations
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China
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University Recruiting
Shanghai, China
Contact: Han    +86 021-33189900-6868    webchao628@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Study Director: Shaoqiang Huang, Dr Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Publications of Results:
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Responsible Party: Chao Han, Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT02532270    
Other Study ID Numbers: CNAP 01
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015
Keywords provided by Chao Han, Fudan University:
obstetric
anesthesia
hypotension
arterial pressure
measurement techniques
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents