A study to compare different infusion plans for preventing low BP and increase acid levels in foetus during elective cesarean.

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/01/048781
• Lead Sponsor: Dr K Shanmathi Devi

Brief Summary

This is a randomized double blinded placebo-controlled comparative study. In this comparative study phenylephrine infusions 25mcg/min and 50 mcg/min is compared with the control groupto maintain the maternal blood pressure and to assess the foetal outcome. Patients posted for caesarean section will undergo a pre anaesthetic examination onthe previous day of the surgery and will be explained about the risks and benefits about the study,surgery and type of anesthesia. Informed consent will be obtained on the day of surgery for theadministration of Anaesthesia and a separate consent will be taken for the enrolment in the study. Patients will receive aspiration prophylaxis of inj.pantoprazole 40mg i.v , and inj.metoclopramide10mg i.v 30 minutes before the surgery. Systolic blood pressure and heart rate will be measured usingstandard non invasive monitoring devices after patient rests in left lateral position for 10 minutes. Meanof the three readings will be taken as the baseline. Systolic blood pressure >20% of basal will beconsidered as reactive hypertension. Systolic blood pressure <20% of the basal or <90mmHg isconsidered as hypotension. Heart rate <20% of basal value or <50/min will be considered asbradycardia. Heart rate >20% of basal value will be considered as tachycardia.Three infusion regimens of Normal saline (control) , PE25 (phenylephrine 25mcg/ml infusion) ,PE50 (phenylephrine 50mcg/ml infusion) are prepared by an Anesthesiologist who is not involved in thestudy. Patients posted for caesarean section and the investigator will be blinded. Patients will be dividedinto three groups and they will be receiving either of the three infusions by computer generatedrandomization.Subarachnoid block will be performed in left lateral position or sitting position using 25GQuinke’s spinal needle at L3-L4 or L4-L5 interspace and 2ml of 0.5%of bupivacaine heavy is injected.Patient will be repositioned in left lateral tilted supine position using a wedge with 10-15 degree. Level of sensory and motor block will be noted.Patient will be given either of the three infusions: normal saline (control group)PE25 or PE50 soon after the subarachnoid block. Infusion will be given at the rate of 60ml/hr by  infusion pump. Heat rate , blood pressure will be recorded every minute for the first 10 minutesof subarachnoid block and every 3 minutes thereafter. Continuous monitoring of electrocardiography,respiratory rate, Spo2 will be done. After the extraction of the baby inj.oxytocin 10U will be given in 500ml ringer lactate slowly and samples will be collected from the double clamped segment of umbilical cord and sent for pH and ABG analysis immediately, APGAR score at 1 and 5 minutes will be recorded. Study drug will be given till 10 minutes after the extraction of baby. Further continuation of theinfusion of the study drug is at the discretion of Anesthesiologist. Any episodes of hypotension will be treated with bolus of inj.phenylephrine 50mcg in all the three groups. Any episode of bradycardia will be treated with inj.Atropine 0.6mg i.v bolus. During the study, if there is any reactive hypertension or bradycardia, it is noted and the infusion will be stopped immediately and will be treated. Infusion will be restarted only if there are any further episodes of hypotension. If the infusion is stopped for more than 3 times during the study then the patient will be excluded from the study

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• 1.ASA physical status II patients.
• 2.Patient not in labour posted for caesarean section under sub arachnoid block.
• 3.Singleton pregnancy.
• 4.Gestational age of more than 36 weeks.

Exclusion Criteria

• 1.Patients with hypertension (SBP >140mmHg, DBP> 90mmHg).
• 2.Diabetes mellitus.
• 3.Cardiovascular disease, cerebrovascular disease.
• 4.Known fetal anomalies.
• 5.Contra-indications to spinal Anaesthesia.
• 6.Signs of onset of labour.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the effectiveness of different concentrations of phenylephrine infusion in preventing the maternal hypotension after the subarachnoid block for caesarean section.	1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min

Secondary Outcome Measures

Name	Time	Method
To assess and compare the effectiveness of phenylephrine infusion in preventing fetal acidosis.	1min,2min,3min,4min,5,min,6min,7min,8min,9min,10min,13min,16min,19min,21min,24min,27min,30min,33min,36min,39min,42min,45min

Trial Locations

Locations (1)

BGS Global Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

BGS Global Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr K Shanmathi Devi

Principal investigator

7708076616

tomy.shanmathi@gmail.com