Different Approaches to Maternal Hypotension During Cesarean Section

NCT00991627 | Completed Phase 4

• 1 other identifier: ANEST-OST-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Neonatal arterial base excess

  <5 min from birth

Secondary Outcomes (10)

• Neonatal arterial and venous pH, venous base excess

  <5 min from birth

• Apgar score

  1 and 5 minutes from birth

• Maternal serum levels of cardiac troponin (baseline, immediate postsurgery, 6 and 12 hours after surgery)

  Baseline and up to 12 h postoperatively

• Incidence of maternal hypotension ( <20% baseline or mean arterial pressure <60 mmHg).

  q5min from anesthesia to end of surgery

• Incidence of maternal bradycardia (heart rate <30% of baseline or <60 beats per minute)

  q5min from anesthesia to end of surgery

Study Arms (2)

Pharmacological

ACTIVE COMPARATOR

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; Drug: Morphine; Drug: Lactated Ringer's solution; Drug: Ephedrine, continuous infusion; Drug: Ephedrine, bolus; Drug: Atropine

Non-Pharmacological

EXPERIMENTAL

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; Drug: Morphine; Drug: Lactated Ringer's solution; Drug: Ephedrine, bolus; Drug: Atropine

Interventions

Bupivacaine DRUG

10 mg of a 5 mg/ml hyperbaric solution, intrathecally

Also known as: Marcain, Local Anesthetic

Non-Pharmacological; Pharmacological

Morphine DRUG

200 µg of a 100 µg/ml solution, intrathecally

Also known as: Intrathecal morphine

Non-Pharmacological; Pharmacological

Lactated Ringer's solution DRUG

25 ml/min intravenously

Non-Pharmacological; Pharmacological

Ephedrine, continuous infusion DRUG

37.5 mg/h intravenously

Pharmacological

Ephedrine, bolus DRUG

6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.

Non-Pharmacological; Pharmacological

Atropine DRUG

0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.

Non-Pharmacological; Pharmacological

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Parma: lead
• Azienda Ospedaliero-Universitaria di Parma: collaborator

Study Sites (1)

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

Parma, PR, 43126, Italy

Location

Related Publications (4)

• Kinsella SM, Lohmann G. Supine hypotensive syndrome. Obstet Gynecol. 1994 May;83(5 Pt 1):774-88.

  PMID: 8164943 BACKGROUND

• 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.

  PMID: 17054153 BACKGROUND

• 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.

  PMID: 15321375 BACKGROUND

• 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.

  PMID: 8678144 BACKGROUND

MeSH Terms

Conditions

Hypotension; Signs and Symptoms

Interventions

Bupivacaine; Anesthetics, Local; Morphine; Ringer's Lactate; Ephedrine; Atropine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic

Study Officials

• Guido Fanelli, MD

  Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

  STUDY CHAIR

• Andrea Cornini, MD

  UO II Anestesia, Rianimazione e Terapia Antalgica, Azienda Ospedaliero-Universitaria di Parma

  STUDY DIRECTOR

• Michele Zasa, MD

  Dept. of Anesthesiology and Critical Care Medicine, University of Parma, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

IT (1)