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

Phase 3
Conditions
Maternal hypotension.
Maternal hypotension syndrome
Registration Number
IRCT2015050622131N1
Lead Sponsor
Vice Chancellor Of Research Zahedan University Of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
120
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.
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