Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Study Overview

• Status: Completed
• Conditions: Anesthesia, Spinal; Anesthesia, Obstetrical
• Intervention / Treatment: Other: Placebo; Drug: Phenylephrine

Detailed Description

Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

• Study Type: Interventional
• Enrollment (Actual): 980
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion Criteria:

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension	Other: Placebo; 5 ml normal saline will be given before spinal anesthesia
Active Comparator: Group B; This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension	Drug: Phenylephrine; it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block	within first 24 hours after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of bradycardia	heart rate will be measured every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block	within first 24 hours after spinal anesthesia
Ephedrine usage	Total amount of ephedrine given	within first 24 hours after spinal anesthesia
intraoperative fluid management	Total amount of fluid given	within first 24 hours after spinal anesthesia
Apgar scores	Apgar scores in the first and fifth minutes of the newborns	within first 24 hours after spinal anesthesia

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Sayed K Abd-Elshafy, MD, Associate professor of anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 4, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hypotension; Cesarean section; Pregnant; Orthostatic; Phenyephrine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: IRB0000871230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED