Different Approaches to Maternal Hypotension During Cesarean Section

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliero-Universitaria di Parma
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00991627
First received: October 7, 2009
Last updated: August 26, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Pregnancy
Cesarean Section
Anesthesia,Spinal
Hypotension
Drug: Bupivacaine
Drug: Morphine
Drug: Lactated Ringer's solution
Drug: Ephedrine, continuous infusion
Drug: Ephedrine, bolus
Drug: Atropine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Neonatal arterial base excess [ Time Frame: <5 min from birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neonatal arterial and venous pH, venous base excess [ Time Frame: <5 min from birth ] [ Designated as safety issue: Yes ]
  • Apgar score [ Time Frame: 1 and 5 minutes from birth ] [ Designated as safety issue: Yes ]
  • Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery) [ Time Frame: Baseline and up to 12 h postoperatively ] [ Designated as safety issue: Yes ]
  • Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg). [ Time Frame: q5min from anesthesia to end of surgery ] [ Designated as safety issue: Yes ]
  • Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute) [ Time Frame: q5min from anesthesia to end of surgery ] [ Designated as safety issue: Yes ]
  • Peripheral arterial oxygen saturation: incidence of desaturation (SpO2 <92%) and mean values for each arm. [ Time Frame: q5min from anesthesia to end of surgery ] [ Designated as safety issue: No ]
  • Administered atropine [ Time Frame: from anesthesia to end of surgery ] [ Designated as safety issue: Yes ]
  • Amount of ephedrine administered (mg) [ Time Frame: from anesthesia to end of surgery ] [ Designated as safety issue: Yes ]
  • Time between induction of anesthesia and skin incision [ Designated as safety issue: No ]
  • Time between skin incision and delivery [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacological
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.
Drug: Bupivacaine
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Other Names:
  • Marcain
  • Local Anesthetic
Drug: Morphine
200 µg of a 100 µg/ml solution, intrathecally
Other Name: Intrathecal morphine
Drug: Lactated Ringer's solution
25 ml/min intravenously
Drug: Ephedrine, continuous infusion
37.5 mg/h intravenously
Drug: Ephedrine, bolus

6.25 mg IV bolus prn.

Hypotension defined according to study protocol for each arm.

Drug: Atropine

0.1 mg/kg iv bolus prn

Bradycardia defined as 50% drop in heart rate from baseline values.

Experimental: Non-Pharmacological
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.
Drug: Bupivacaine
10 mg of a 5 mg/ml hyperbaric solution, intrathecally
Other Names:
  • Marcain
  • Local Anesthetic
Drug: Morphine
200 µg of a 100 µg/ml solution, intrathecally
Other Name: Intrathecal morphine
Drug: Lactated Ringer's solution
25 ml/min intravenously
Drug: Ephedrine, bolus

6.25 mg IV bolus prn.

Hypotension defined according to study protocol for each arm.

Drug: Atropine

0.1 mg/kg iv bolus prn

Bradycardia defined as 50% drop in heart rate from baseline values.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991627

Locations
Italy
University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)
Parma, PR, Italy, 43126
Sponsors and Collaborators
University of Parma
Azienda Ospedaliero-Universitaria di Parma
Investigators
Study Chair: Guido Fanelli, MD Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
Study Director: Andrea Cornini, MD UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
Principal Investigator: Michele Zasa, MD Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy
  More Information

Publications:
Responsible Party: Guido Fanelli, UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT00991627     History of Changes
Other Study ID Numbers: ANEST-OST-02
Study First Received: October 7, 2009
Last Updated: August 26, 2010
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by University of Parma:
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

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Anesthetics
Atropine
Bupivacaine
Central Nervous System Stimulants
Ephedrine
Morphine
Pharmaceutical Solutions
Pseudoephedrine
Adjuvants, Anesthesia
Adrenergic Agents
Analgesics
Analgesics, Opioid
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Narcotics
Nasal Decongestants

ClinicalTrials.gov processed this record on October 29, 2014