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A study comparing the impact of prophylactic infusion of two different doses of phenylephrine on maternal hypotension and outcome of newborns in females undergoing cesarean section under spinal anaesthesia.

A study to compare the effect of prophylactic infusion of two different doses of phenylephrine on maternal hypotension and neonatal outcome in females undergoing cesarean section under spinal anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047845
Enrollment
60
Registered
2022-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: O746- Other complications of spinal andepidural anesthesia during labor and delivery

Interventions

Intervention1: Spinal anaesthesia: To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 vs 50 micrograms/minute) administered for 3 minutes after in

Sponsors

Department of Anaesthesia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with physical status ASA grade I or II. 2. All patients giving written informed consent. 3. Patients with gestation age > 36 weeks posted for elective caesarean delivery under spinal anaesthesia. 4. Patients belonging to age group of 18 to 35 years.

Exclusion criteria

Exclusion criteria: 1. Parturients with complications like risk of excessive bleeding (placenta previa, prolonged labor, abnormal presentation, multiple gestation) 2. Patients with pre-existing or pregnancy induced hypertension or maternal SBP 3. Patients with cardiovascular disease, cerebrovascular disease, severe anemia or diabetes. 4. Patients with known fetal abnormalities. 5. Patients with contraindication to spinal anaesthesia. 6. Patients with known allergy to phenylephrine 7. Patients with inability or refusal to give informed consent

Design outcomes

Primary

MeasureTime frame
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50 micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia. -To assess the changes in maternal blood pressure -To assess the changes in maternal heart rate. Timepoint: From administration of spinal anaesthesia intraoperstively till the end of the surgery.

Secondary

MeasureTime frame
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50â?¢ micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia. â?¢To assess the incidence of nausea and vomiting â?¢To assess the fetal outcomes in terms of APGAR score and acidosis. Timepoint: From administration of spinal anaesthesia intraoperstively till the end of the surgery.

Countries

India

Contacts

Public ContactBabita Ramdev

Maharishi Markandeshwar University,Mullana

babitaramdev30@gmail.com7888554917

Outcome results

None listed

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