Manging Post Spinal Hypotension During Elective Cesarean Section

NCT03704909 | Completed Phase 4

• 1 other identifier: Adrenaline
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Conditions

Hypotension

Keywords

Epinephrine, Ephedrine, cesarean section, spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• delta SBP (D)

  difference between baseline and the lowest systolic blood pressure.

  at the end of intrathecal injection until delivery

• delta MBP (D)

  difference between baseline and the lowest mean blood pressure.

  at the end of intrathecal injection until delivery

Secondary Outcomes (15)

• delta SBP (S)

  at the end of intrathecal injection until the end of surgery

• delta MBP (S)

  at the end of intrathecal injection until the end of surgery

• time to onset of first post spinal hypotension episode

  At time of surgery (right after spinal anesthesia until end of surgery)

• Incidence of post spinal hypotension

  At time of surgery (right after spinal anesthesia until end of surgery)

• Vasopressor consumption

  from the end of intrathecal injection until delivery.

Study Arms (2)

Group Adrenaline: Group A

ACTIVE COMPARATOR

All parturients received a prophylactic i.v bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.

Drug: Adrenaline

Group Ephedrine: Group E

ACTIVE COMPARATOR

All parturients received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.E

Drug: Ephedrine

Interventions

Adrenaline DRUG

i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg

Also known as: epinehrine

Group Adrenaline: Group A

Ephedrine DRUG

i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg

Group Ephedrine: Group E

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II
• BMI\>18 and \<35 Kg/m2
• full term parturients with singleton pregnancy
• scheduled of elective cesarean section under spinal anesthesia
• Patient refusal.
• ASA \> II
• Preexisting or pregnancy-induced hypertension
• The use of cardiac medication or medication for BP control.
• Cardiovascular or cerebrovascular disease.
• Multiple pregnancy.
• Suspicion of abnormal placentation.
• Known fetal abnormalities or fetal distress.
• CS under general anesthesia.
• Active labor.
• Emergency.

You may not qualify if:

• Hemodynamic instability that is not in relationship with SA (occurrence of a surgical per-operative complication e.g. bleeding by placental insertion abnormality or a uterine atony).
• An abnormal extension of the anesthetic block defined as a sensory block level \> D4.
• SA failure.
• The need to convert to general anesthesia.

Sponsors & Collaborators

• Ben marzouk Sofiene: lead

Study Sites (1)

Tunis maternity and neonatology center,

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Hypotension

Interventions

Epinephrine; Ephedrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propanolamines; Propanols; Phenethylamines; Ethylamines

Study Officials

• HAYEN MAGHREBIG, PROFESSOR

  UNIVERSITY OF TUNIS EL MANAR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical associate professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TU (1)