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.

Not yet recruiting

• Conditions: Other complications of spinal andepidural anesthesia during labor and delivery,

• Registration Number: CTRI/2022/12/047845
• Lead Sponsor: Department of Anaesthesia

Brief Summary

Spinal anaesthesia is nowadays preferred over General anaesthesia for caesarean sections as it not only overcomes the complications associated with general anaesthesia but also provides more effective pain control, early ambulation and better maternal and fetal outcomes.Intraoperative hypotension is defined as decrease in mean blood pressure less than 20% of patient’s baseline value. It can occur after spinal anaesthesia and may have deleterious effects on maternal and fetal outcomes.The effects of various vasopressors like ephedrine, nor-epinephrine, mephenteramine, phenylephrine, etc. have been studied in the prevention of spinal hypotension.Considering the influences on fetomaternal physiology like minimal placental passage, less incidence of fetoacidosis and maternal nausea, vomiting, etc. phenylephrine has been found to be the vasopressor of choice.Therefore we will be doing this random prospective study to compare two rates of infusion of phenylephrine (25 and 50 micrograms/minute) in preventing maternal hypotension caused by spinal anaesthesia and neonatal outcomes in patients undergoing caesarean section.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-11-30
• Study Start: 2022-12-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

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

• 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< 100mm Hg. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	From administration of spinal anaesthesia intraoperstively till the end of the surgery.
-To assess the changes in maternal blood pressure	From administration of spinal anaesthesia intraoperstively till the end of the surgery.
-To assess the changes in maternal heart rate.	From administration of spinal anaesthesia intraoperstively till the end of the surgery.

Secondary Outcome Measures

Name	Time	Method
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 incidence of nausea and vomiting

Trial Locations

Locations (1)

MM Institute of Medical Sciences and Research Centre; 🇮🇳 Ambala, HARYANA, India

MM Institute of Medical Sciences and Research Centre

🇮🇳Ambala, HARYANA, India

Ashita Rukmini

Principal investigator

9896389305

ashitarukmini44@gmail.com