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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02979405
Other study ID # UIS 2016
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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