Role of Dexamethasone in prevention of blood pressure reduction after spinal anesthesia in patient undergoing caesarean section – a randomized double blind placebo controlled study.

Completed

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2021/08/035777
• Lead Sponsor: All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Pin Odisha India

Brief Summary

Spinal anesthesia is the most commonly used anesthesia technique in caesareansection but it has many side effects like hypotension, bradycardia, nausea,vomiting. Incidence of hypotension and bradycardia in non-obstetric populationis 33% and 13% but in obstetric population the incidence of post spinalhypotension is around 60%. (1) Using vasopressor has been highly recommendedfor routine prevention of post spinal hypotension during caesarean delivery.The commonly used vasopressor during caesarean delivery is phenylephrine butphenylephrine sometime causes maternal cardiac depression. (2) Nor adrenalineis another vasopressor characterized by alpha agonistic activity in addition toa weak beta agonistic activity so nor adrenaline is considered a vasopressorwith less cardiac depression effect (3) along with this dexamethasone shown toreduce post spinal hypotension by blunting Bezold Jarish reflux and increasingperipheral vascular resistance. (4)

Parturients scheduledfor caesarean section who will meet the inclusion criteria will be sensitizedregarding the study using the patient information sheet [both in English andodia] during the pre-anesthesia check-up.

Patients will be randomly allocated into two groups using a computer-generated randomizationchart to receiveeither intravenousdexamethasone 8mg (4)in the (Group A) and 2 ml normal saline in (group B) 15 minutes beforespinal anesthesia.(9, 10)

In the operating room, standard ASA monitors willbe attached (electrocardiography,pulse oximetry, non-invasive blood pressuremonitor).

Then spinalanesthesia technique will be performedwith the patient in the sitting position at L3-4 or L4-5level with 0.5% hyperbaric bupivacaine 10 to 12mg + 20 mcg fentanyl. The drugs will be administered intrathecally afterconï¬rmation of free backflow of cerebrospinal fluid througha 25-gauge Quinckespinal needle. SBP and HR will bemeasured for every 3 min till the deliveryof the baby.

References:

1.Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-                                  inducedhypotension with ondansetron in parturients undergoing caesarean section: adouble-blind randomised, placebo- controlled study. Int J Obstet Anesth.2012;21(1):24–8.

 2.Hasanin A, Mokhtar AM, Badawy AA, Fouad R. Post-spinal anesthesia hypotensionduring caesarean delivery, a review article. Egypt J Anaesth.2017;33(2):189–93.

 3.Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, et al.Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension duringCaesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology.2019;130(1):55–62.

 4.Ashoor TM, Hussien NS, Anis SG, Esmat IM. Dexamethasone blunts postspinalhypotension in geriatric patients undergoing orthopedic surgery: a doubleblind, placebo-controlled study. BMC Anesthesiol. 2021;21(1):11.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Study Completion: 2023-01-29
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

ASA II females with normal singleton pregnancies with a gestation of ≥ 37 weeks, and scheduled for Caesarean Section under spinal anaesthesia.

Exclusion Criteria

• Chronic hypertension 2.Pregnancy induced hypertension 3.Gestational diabetes 4.Height<140cms or >180cms 5.Contraindication for spinal anesthesia 6.Weight >100kg 7.Known Allergy to dexamethasone 8.
• Patient received Dexamethasone within 48hrs.
• Patient refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Hypotension	SBP and HR will be measured for every 3 min till the delivery of the baby.

Secondary Outcome Measures

Name	Time	Method
1. Episodes of hypotension	2.Episodes of hypertension

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

All India Institute of Medical Sciences, Bhubaneswar

🇮🇳Khordha, ORISSA, India

Dr S Poornachanthar

Principal investigator

8667313702

poornachantharan@gmail.com