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Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02958215
Enrollment
980
Registered
2016-11-08
Start date
2016-06-30
Completion date
2017-05-31
Last updated
2017-05-18

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

Conditions

Anesthesia, Obstetrical, Anesthesia, Spinal

Keywords

Orthostatic, Cesarean section, Pregnant, Phenyephrine, Hypotension

Brief summary

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Detailed description

Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension OH is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Interventions

DRUGPhenylephrine

it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section

OTHERPlacebo

5 ml normal saline will be given before spinal anesthesia

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion criteria

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypotensionwithin first 24 hours after spinal anesthesiablood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block

Secondary

MeasureTime frameDescription
Frequency of bradycardiawithin first 24 hours after spinal anesthesiaheart rate will be measured every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
Ephedrine usagewithin first 24 hours after spinal anesthesiaTotal amount of ephedrine given
intraoperative fluid managementwithin first 24 hours after spinal anesthesiaTotal amount of fluid given
Apgar scoreswithin first 24 hours after spinal anesthesiaApgar scores in the first and fifth minutes of the newborns

Countries

Egypt

Outcome results

None listed

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