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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension Drug-Induced
• Intervention / Treatment: Drug: Phenylephrine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Santander
    • Bucaramanga, Santander, Colombia, 68003
      • Clinic materno infaltil San Luis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; Phenylephrine 40 mcg/min, infusion during 5 minutes	Drug: Phenylephrine; prophylactic infusion of phenylephrine 40 mcg/min; Other Names: prophylactic Phenylephrine
Placebo Comparator: group 2; Saline solution 21 cc, infusion during 5 minutes	Drug: Phenylephrine; prophylactic infusion of phenylephrine 40 mcg/min; Other Names: prophylactic Phenylephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hypotension	caesarean delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
heart rate	caesarean delivery
Newborn APGAR	Turn off of the newly born: measured to the 1 and 5 minutes from the birth

Other Outcome Measures

Outcome Measure	Time Frame
Nausea	surgical procedure
Vomiting	surgical procedure

Collaborators and Investigators

• Sponsor: Universidad Industrial de Santander
• Investigators: Study Director: Hector Meléndez, Dr, Universidad Industrial de Santander

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): February 20, 2017
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• 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: UIS 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No