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Different Approaches to Maternal Hypotension During Cesarean Section

Primary Purpose

Pregnancy, Cesarean Section, Anesthesia,Spinal

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Bupivacaine
Morphine
Lactated Ringer's solution
Ephedrine, continuous infusion
Ephedrine, bolus
Atropine
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Ephedrine, Adrenergic Agents, Central Nervous System Stimulants, Sympathomimetics, Vasoconstrictor Agents, Bupivacaine, Anesthetics, Local, Atropine, Adjuvants, Anesthesia, Anti-Arrhythmia Agents, Bronchodilator Agents, Muscarinic Antagonists, Mydriatics, Parasympatholytics, Morphine, Analgesics, Opioid, Narcotics, Ringer's Lactate, Isotonic Solutions, Hypotension, Blood pressure, Signs and Symptoms, Pregnancy, Anesthesia, Obstetrical, Inferior Vena Cava

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing spinal anesthesia for elective Cesarean section
  • Patients in ASA Physical Status Class I or II
  • Informed written consent to participation
  • Positive Supine Stress Test

Exclusion Criteria:

  • Any known fetal pathology
  • Indication to general anesthesia
  • Known allergy to any of the study drugs

Sites / Locations

  • University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pharmacological

Non-Pharmacological

Arm Description

Patients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values.

Patients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values.

Outcomes

Primary Outcome Measures

Neonatal arterial base excess

Secondary Outcome Measures

Neonatal arterial and venous pH, venous base excess
Apgar score
Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)
Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).
Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)
Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.
Administered atropine
Amount of ephedrine administered (mg)
Time between induction of anesthesia and skin incision
Time between skin incision and delivery

Full Information

First Posted
October 7, 2009
Last Updated
August 26, 2010
Sponsor
University of Parma
Collaborators
Azienda Ospedaliero-Universitaria di Parma
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1. Study Identification

Unique Protocol Identification Number
NCT00991627
Brief Title
Different Approaches to Maternal Hypotension During Cesarean Section
Official Title
Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Parma
Collaborators
Azienda Ospedaliero-Universitaria di Parma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.
Detailed Description
The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy. Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones. According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation. Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava. The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Cesarean Section, Anesthesia,Spinal, Hypotension
Keywords
Ephedrine, Adrenergic Agents, Central Nervous System Stimulants, Sympathomimetics, Vasoconstrictor Agents, Bupivacaine, Anesthetics, Local, Atropine, Adjuvants, Anesthesia, Anti-Arrhythmia Agents, Bronchodilator Agents, Muscarinic Antagonists, Mydriatics, Parasympatholytics, Morphine, Analgesics, Opioid, Narcotics, Ringer's Lactate, Isotonic Solutions, Hypotension, Blood pressure, Signs and Symptoms, Pregnancy, Anesthesia, Obstetrical, Inferior Vena Cava

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacological
Arm Type
Active Comparator
Arm Description
Patients in this group will receive a basal infusion of ephedrine. Hypotension will be treated for a reduction in systolic blood pressure 20% below baseline values.
Arm Title
Non-Pharmacological
Arm Type
Experimental
Arm Description
Patients in this group will undergo uterine lateral displacement through the use of a wedge-shaped cushion placed under their right hip. Hypotension will be treated for a reduction in systolic blood pressure 40% below baseline values.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcain, Local Anesthetic
Intervention Description
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Intrathecal morphine
Intervention Description
200 µg of a 100 µg/ml solution, intrathecally
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Intervention Description
25 ml/min intravenously
Intervention Type
Drug
Intervention Name(s)
Ephedrine, continuous infusion
Intervention Description
37.5 mg/h intravenously
Intervention Type
Drug
Intervention Name(s)
Ephedrine, bolus
Intervention Description
6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.
Primary Outcome Measure Information:
Title
Neonatal arterial base excess
Time Frame
<5 min from birth
Secondary Outcome Measure Information:
Title
Neonatal arterial and venous pH, venous base excess
Time Frame
<5 min from birth
Title
Apgar score
Time Frame
1 and 5 minutes from birth
Title
Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)
Time Frame
Baseline and up to 12 h postoperatively
Title
Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).
Time Frame
q5min from anesthesia to end of surgery
Title
Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)
Time Frame
q5min from anesthesia to end of surgery
Title
Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm.
Time Frame
q5min from anesthesia to end of surgery
Title
Administered atropine
Time Frame
from anesthesia to end of surgery
Title
Amount of ephedrine administered (mg)
Time Frame
from anesthesia to end of surgery
Title
Time between induction of anesthesia and skin incision
Title
Time between skin incision and delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing spinal anesthesia for elective Cesarean section Patients in ASA Physical Status Class I or II Informed written consent to participation Positive Supine Stress Test Exclusion Criteria: Any known fetal pathology Indication to general anesthesia Known allergy to any of the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Fanelli, MD
Organizational Affiliation
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea Cornini, MD
Organizational Affiliation
UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michele Zasa, MD
Organizational Affiliation
Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
8164943
Citation
Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.
Results Reference
background
PubMed Identifier
17054153
Citation
Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.
Results Reference
background
PubMed Identifier
15321375
Citation
Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.
Results Reference
background
PubMed Identifier
8678144
Citation
Helwig JT, Parer JT, Kilpatrick SJ, Laros RK Jr. Umbilical cord blood acid-base state: what is normal? Am J Obstet Gynecol. 1996 Jun;174(6):1807-12; discussion 1812-4. doi: 10.1016/s0002-9378(96)70214-4.
Results Reference
background

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Different Approaches to Maternal Hypotension During Cesarean Section

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