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Evaluation of the effect of phenylephrine on spinal anesthesia induced hypotension in cesarean section

Comparison between different prophylactic & therapeutic phenylephrine regimenes in reducing maternal hypotention after induction of spinal anesthesia in caesarean section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201601238768N4
Enrollment
120
Registered
2016-10-09
Start date
2016-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

spinal anesthesia induced hypotension. Other complications of spinal and epidural anaesthesia during labour and delivery

Interventions

Intervention 1: Intervention1: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) 100 microgram phenylephrin in 1 cc volume will be injected and then infus
Treatment - Drugs
Intervention1: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) 100 microgram phenylephrin in 1 cc volume will be injected and then infusion of normal sa
Intervention 2: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of phenylephrine 50 m
Control group: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of normal saline will be

Sponsors

Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: All of the ASA 1 healthy term parturients referring to Fatemieh hospital candidate for Cesarean section were included in the study. Exclusion criteria: chronic hypertension; pre eclampsia; twin pregnancy;, preterm labor; allergy to drugs; cardiovascular disease; renal disease and previous abdominal surgeries with adhesion band and fibrosis.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Spinal anesthesia induced blood pressure change. Timepoint: before performing spinal anesthesia, every 2 minutes until delivery and then every 5 minutes until the end of surgery. Method of measurement: blood pressure was measured with automatic blood pressure device and hypotension was defined as more than 20% decrease of BP compared to baseline.

Secondary

MeasureTime frame
Heart rate. Timepoint: before performing spinal anesthesia and then every 5 minutes until the end of surgery. Method of measurement: Electrocardiogram monitoring.;Nausea. Timepoint: every 5 minutes until the end of surgery. Method of measurement: observation.;Vomiting. Timepoint: every 5 minutes until the end of surgery. Method of measurement: observation.;Rescue vasopressor dose. Timepoint: at the end of surgery. Method of measurement: measurement.;Neonatal condition. Timepoint: at min 1 and 5. Method of measurement: Apgar score mesurements by observation and physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Nikooseresht M.D

Hamadan University of Medical Sciences

nikooseresht@umsha.ac.ir+98 81 3264 0049

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026