Skip to main content
OpenTrials
Completed

NCT Number: NCT02979405

Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery

Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Clinic materno infaltil San Luis

Bucaramanga, Santander Department, 68003, Colombia

About this study

Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
  • Gestational age >37 weeks

Exclusion criteria

Pregnant subjects with:

  • Hipertensive disorders in pregnancy
  • Acute fetal distress
  • Evidence of placental dysfunction
  • History of cardiovascular or cerebrovascular diseases
  • hypersensitivity to phenylephrine
  • Rejection of the patient

Treatment and study plan

Phenylephrine

Drug

prophylactic infusion of phenylephrine 40 mcg/min

Other names: prophylactic Phenylephrine

Primary outcomes

  1. Hypotension

    Time frame: caesarean delivery

Secondary outcomes

  1. heart rate

    Time frame: caesarean delivery

  2. Newborn APGAR

    Time frame: Turn off of the newly born: measured to the 1 and 5 minutes from the birth

Other outcomes

  1. Nausea

    Time frame: surgical procedure

  2. Vomiting

    Time frame: surgical procedure

Sponsors and collaborators

Lead sponsor

Universidad Industrial de Santander

Other

Registry information

Official study title

Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Feb 24, 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.

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