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

Universidad Industrial de Santander

Status and phase: Completed; Phase 4

Conditions: Hypotension Drug-Induced

Treatments: Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02979405

UIS 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

group 1

Experimental group

Description:

Phenylephrine 40 mcg/min, infusion during 5 minutes

Treatment:

Drug: Phenylephrine

group 2

Placebo Comparator group

Description:

Saline solution 21 cc, infusion during 5 minutes

Treatment:

Drug: Phenylephrine