Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

NCT03015857 | Completed Phase 2

• 1 other identifier: cesarean sections
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

Conditions

Adverse Anesthesia Outcome

Outcome Measures

Primary Outcomes (1)

• Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)

  2 hours

Secondary Outcomes (3)

• systolic and diastolic blood pressures measured in mm Hg

  2 hours

• heart rate measured in beats per minute

  2 hours

• nausea and vomiting measured in number of attacks

  2 hours

Study Arms (2)

phenylephrine,

ACTIVE COMPARATOR

\- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.

Drug: phenylephrine; Drug: Bupivacaine; Drug: Fentanyl; Drug: Placebo (normal saline)

norepinephrine

ACTIVE COMPARATOR

\- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.

Drug: Norepinephrine; Drug: Bupivacaine; Drug: Fentanyl

Interventions

phenylephrine DRUG

\- phenylephrine; a vasopressor drug given to prevent post spinal hypotension

phenylephrine,

Norepinephrine DRUG

\- norepinephrine; a vasopressor drug given to prevent post spinal hypotension

norepinephrine

Bupivacaine DRUG

intrathecal bupivacaine 10 mg will be given in both groups

norepinephrine; phenylephrine,

Fentanyl DRUG

intrathecal fentanyl 20 mcg will be given in both groups

norepinephrine; phenylephrine,

Placebo (normal saline) DRUG

phenylephrine,

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• full term singleton parturients
• elective cesarean sections

You may not qualify if:

• cardiac morbidities
• hypertensive disorders of pregnancy
• peripartum bleeding
• body mass index \> 35 will be excluded from the study

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

MeSH Terms

Interventions

Phenylephrine; Norepinephrine; Bupivacaine; Fentanyl; Saline Solution

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shereen Refaat, M.D.

  Lecturer of anesthesia Faculty of medicine Cairo university

  STUDY CHAIR

• Tamer M Rook, M.D.

  Lecturer of anesthesia Faculty of medicine Cairo university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and lecturer of anesthesia, faculty of medicine cairo university

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: January 10, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05