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Comparison of Intravenous Phenylephrine and Ephedrine to Treat Hypotension Associated with Spinal Anesthesia in Patients Undergoing Cesarean Section

Comparison of Intravenous Phenylephrine and Ephedrine to Treat Hypotension Associated with Spinal Anesthesia in Patients Undergoing Cesarean Section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015050622131N1
Enrollment
120
Registered
2015-09-19
Start date
2015-07-23
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

Maternal hypotension. Maternal hypotension syndrome

Interventions

Intervention 1: Bolus injection of 5 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 5 mg. Intervention 2: Bolus injection of 10 mg ephedrine if hypotension
Treatment - Drugs
Bolus injection of 5 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 5 mg
Bolus injection of 10 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose,10 mg
Bolus injection of 50µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 50µg
Bolus injection of 100 µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 100 µg

Sponsors

Vice Chancellor Of Research Zahedan University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Pregnant women 2o-35 years old ;Elective cesarean;ASA1; Singleton pregnancy;36 to 40 weeks gestational age;Weighing 45 to 90 kg;145 to 180 cm height;Informed consent for inclusion Exclusion criteria beginning: History of Primary hypertension (Bp=140/90);cardio-cerebrovascular diseases; Diabetic mellitus;Sensitivity to anesthetics;Pregnancy complications such as gestational hypertension;Placental abnormalities;Umbilical cord abnormalities;High-risk pregnancies(Multiple pregnancy?Intrauterine growth retardation);Spinal anesthesia ban(Prevention of spinal anesthesia?Coagulation disorder?Infection of spinal anesthesia area);Lack of consent to participate in the study Exclusion criteria during the study:Unpredictable events during surgery such as abnormal hemorrhage under surgery; unsuccessful spinal anesthesia;high spinal Anesthesia (at level above T4); more than 75min surgery duration

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Blood pressure. Timepoint: After spinal anesthesia,75 minutes (every 3 minutes for the first 15-minute period and every 10 minutes for the following 60-minute period. Method of measurement: mmHg by SIEMENS SC 7000 monitoring system.;Heart rate. Timepoint: After spinal anesthesia, were checked for 75 minutes (every 3 minutes for the first 15-minute period and every 10 minutes for the following 60-minute period. Method of measurement: Number by SIEMENS SC 7000 Monitoring system.

Secondary

MeasureTime frame
Base Exess. Timepoint: After the extraction of fetus and umbilical cord clamp. Method of measurement: Number -Based on the arterial umbilical cord Base Exess,that was measured by blood gas analyzer ,GASTAT-603ie.;Nausea. Timepoint: During Surgery. Method of measurement: Has/has not,Patient-reported.;Vomiting. Timepoint: During Surgery. Method of measurement: Has/has not,Observer-reported.;Umbilical cord Ph. Timepoint: After the extraction of fetus and umbilical cord clamp. Method of measurement: Number -Based on the arterial umbilical cord PH,that was measured by blood gas analyzer ,GASTAT-603ie.;Neonatal Apgar. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Based on clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedayatollah Vakili

Zahedan University of Medical Sciences

vakili_h@sums.ac.ir+98 71 3843 8875

Outcome results

None listed

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