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

NCT ID: NCT02979405

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2017-02-21

Brief 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.

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.

Conditions

Hypotension Drug-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group 1

Phenylephrine 40 mcg/min, infusion during 5 minutes

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

prophylactic infusion of phenylephrine 40 mcg/min

group 2

Saline solution 21 cc, infusion during 5 minutes

Group Type: PLACEBO_COMPARATOR

Phenylephrine

Intervention Type: DRUG

prophylactic infusion of phenylephrine 40 mcg/min

Interventions

Phenylephrine

prophylactic infusion of phenylephrine 40 mcg/min

Intervention Type: DRUG

Other Intervention Names

prophylactic Phenylephrine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Industrial de Santander

OTHER

Sponsor Role: lead

Responsible Party

Nelly Johanna Puentes Vega

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hector Meléndez, Dr

Role: STUDY_DIRECTOR

Universidad Industrial de Santander

Locations

Clinic materno infaltil San Luis

Bucaramanga, Santander Department, Colombia

Countries

Colombia

Other Identifiers

UIS 2016

Identifier Type: -

Identifier Source: org_study_id