A study to know which method is better to prevent fall in blood pressure in cesarean section

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2020/02/023526
• Lead Sponsor: Bangalore Baptist Hospital

Brief Summary

Hypotension is one of the most commonimmediate complications of spinal anesthesia. Preloading with fluids is one wayof preventing hypotension. However hypotension still occurs in many patientswhich is managed by pharmacological interventions. In this study, we arecomparing three modalities which can prevent hypotension. Based on the findingsof the study, we want to standardize the care in our hospital.

There are no studies comparing theuse of head elevated position and intravenous Ondansetron in reducing spinalinduced hypotension in obstetrics. Both these interventions are simple, costeffective and carry negligible risk hence were chosen for the study.

Group H: Parturients will receivehead end elevation during and after spinal anaesthesia and will remain in thisposition till the end of the surgery. They will not receive Inj. Ondansetronprior to spinal anesthesia.

Group O; Parturients will receive Inj.Ondanstron 4 mg i.v five minutes prior to spinal anesthesia.

Group C: Parturients will neither begiven head end elevation post spinal anaesthesia nor will receive Inj.Ondansetron i.v prior to spinal anaesthesia.(standard of care)

Standard protocol for perioperativemonitoring and administration of spinal anaesthesia will be followed.

Hemodynamic parameters which include systolic, diastolic andmean arterial pressures and heart rate will be measured and recorded beforespinal anaesthesia administration, just after spinal anaesthesia, at 1 minuteintervals for the first 5 minutes, then at 5 minute intervals till the end ofsurgery.

The total dose ofephedrine required will be noted

Sensory block will be assessed using a cold swab and motor blockby modified Bromage scale every 3 minutes for 15 minutes, beyond which parturientwill be excluded if sensory block is below T6.

Time from spinalinjection to T6 sensory level, maximal sensory block level (MSBL) attained,time at which MSBL was achieved, time to skin incision, time to two segmentregression of the sensory block will be recorded.

Other side effects of spinal anesthesia like nausea, vomitingand shivering will be noted.

 APGAR at 1minute and 5 minutes will also be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-03
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 750

Inclusion Criteria

Parturients for Cesarean Section.

Exclusion Criteria

BMI >35 ASA3 Severe fetal distress Obstetric complications Medical disease complicating pregnancy Sitting position Drug volume> or< than 2 ml Contraindication to spinal anesthesia Allergy to ondansetron Parturients on medicines acting on 5HT3 Conversion to general anesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fall in Blood pressure	After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute

Secondary Outcome Measures

Name	Time	Method
Vomiting, maximal sensory block level, bradycardia,	After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute

Trial Locations

Locations (1)

Operation Theatre Bangalore Baptist Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Operation Theatre Bangalore Baptist Hospital

🇮🇳Bangalore, KARNATAKA, India

Mita Eunice Sarkar

Principal investigator

9980670790

mitasarkar7@yahoo.com