NCT02532270

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

August 13, 2015

Last Update Submit

November 5, 2015

Conditions

Hypotension

Keywords

obstetricanesthesiahypotensionarterial pressuremeasurement techniques

Outcome Measures

Primary Outcomes (1)

  • the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement

    (baseline SBP-minimum SBP)/baseline SBP

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

Secondary Outcomes (6)

  • Detecting the occurrence of hypotension

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

  • Neonatal outcome was assessed with Apgar scores

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

  • umbilical cord blood gases analysis at birth

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

  • the incidence of nausea and vomiting on account of hypotension

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

  • the incidence of dizziness on account of hypotension

    between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

  • +1 more secondary outcomes

Study Arms (2)

Group C

EXPERIMENTAL

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

Group N

EXPERIMENTAL

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

Interventions

phenylephrineDRUG

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.

Also known as: Phenylephrine Hydrochloride
Group CGroup N

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University

Shanghai, China

RECRUITING

Related Publications (5)

  • Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.

    PMID: 22798273RESULT

  • Jeleazcov C, Krajinovic L, Munster T, Birkholz T, Fried R, Schuttler J, Fechner J. Precision and accuracy of a new device (CNAPTM) for continuous non-invasive arterial pressure monitoring: assessment during general anaesthesia. Br J Anaesth. 2010 Sep;105(3):264-72. doi: 10.1093/bja/aeq143. Epub 2010 Jul 13.

    PMID: 20627878RESULT

  • Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.

    PMID: 19859776RESULT

  • Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.

    PMID: 11916798RESULT

  • Maayan-Metzger A, Schushan-Eisen I, Todris L, Etchin A, Kuint J. Maternal hypotension during elective cesarean section and short-term neonatal outcome. Am J Obstet Gynecol. 2010 Jan;202(1):56.e1-5. doi: 10.1016/j.ajog.2009.07.012. Epub 2009 Aug 28.

    PMID: 19716536RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Shaoqiang Huang, Dr

    Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University

    STUDY DIRECTOR

Central Study Contacts

Han

CONTACT

+86 021-33189900-6868webchao628@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 25, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

CN(1)