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

Hypotension Drug-Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979405
• Other study ID #: UIS 2016
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2016
• Last updated: February 22, 2017
• Start date: January 17, 2017
• Est. completion date: February 21, 2017

Study information

• Verified date: February 2017
• Source: Universidad Industrial de Santander
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 21, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Phenylephrine
prophylactic infusion of phenylephrine 40 mcg/min

Locations

Country	Name	City	State
Colombia	Clinic materno infaltil San Luis	Bucaramanga	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Industrial de Santander

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea		surgical procedure
Other	Vomiting		surgical procedure
Primary	Hypotension		caesarean delivery
Secondary	heart rate		caesarean delivery
Secondary	Newborn APGAR		Turn off of the newly born: measured to the 1 and 5 minutes from the birth