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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02979405
Enrollment
140
Registered
2016-12-01
Start date
2017-01-17
Completion date
2017-02-21
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension Drug-Induced

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.

Interventions

DRUGPhenylephrine

prophylactic infusion of phenylephrine 40 mcg/min

Sponsors

Universidad Industrial de Santander
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Hypotensioncaesarean delivery

Secondary

MeasureTime frame
heart ratecaesarean delivery
Newborn APGARTurn off of the newly born: measured to the 1 and 5 minutes from the birth

Other

MeasureTime frame
Nauseasurgical procedure
Vomitingsurgical procedure

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026