Skip to main content
OpenTrials
Completed

NCT Number: NCT02958215

Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Obstetrical Anesthesia, Spinal Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenylephrine

Drug

it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

Placebo

Other

5 ml normal saline will be given before spinal anesthesia

Primary outcomes

  1. Incidence of hypotension

    Time frame: within first 24 hours after spinal anesthesia

    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

Secondary outcomes

  1. Frequency of bradycardia

    Time frame: within first 24 hours after spinal anesthesia

    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

  2. Ephedrine usage

    Time frame: within first 24 hours after spinal anesthesia

    Total amount of ephedrine given

  3. intraoperative fluid management

    Time frame: within first 24 hours after spinal anesthesia

    Total amount of fluid given

  4. Apgar scores

    Time frame: within first 24 hours after spinal anesthesia

    Apgar scores in the first and fifth minutes of the newborns

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.