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CTRI Number  CTRI/2021/08/035777 [Registered on: 18/08/2021] Trial Registered Prospectively
Last Modified On: 22/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of Dexamethasone in prevention of blood pressure reduction after spinal anesthesia in patient undergoing caesarean section – a randomized double blind placebo controlled study. 
Scientific Title of Study   . Role of Dexamethasone in preventing post spinal hypotension in patient undergoing caesarean section – a randomized double blind placebo controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar  
Address  Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar  
Address  Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax    
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr S Poornachanthar 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, Bhubaneswa 
Address  Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India

Khordha
ORISSA
751019
India 
Phone  8667313702   
Fax    
Email  poornachantharan@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Pin Odisha India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Pin Odisha India  
Address  All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Poornachanthar  All India Institute of Medical Sciences, Bhubaneswar   Labor OT complex, Second floor(for the immediate post-operative follow-up) and Obstetric Ward, Second floor (for follow-up at the later time points, AIIMS, Bhubaneswar. Khordha ORISSA
Khordha
ORISSA 		 8667313702

poornachantharan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone vs Placebo injection  Same volume of the normal saline will be given. 
Intervention  Study drug will be given 15 min before spinal anesthesia and blood pressure measurement was done intra op in patient undergoing caesarean section  Study drug is Dexamethasone 8 mg intravenous route. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  ASA II females with normal singleton pregnancies with a gestation of ≥ 37 weeks, and scheduled for Caesarean Section under spinal anaesthesia.  
 
ExclusionCriteria 
Details  1. 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.
9. Patient refusal
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Hypotension  SBP and HR will be measured for every 3 min till the delivery of the baby. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Episodes of hypotension
2.Episodes of hypertension
3.Episodes of bradycardia
4.APGAR score 1min and 5min
5.Umbilical blood gas analysis
[pO2, pCO2 and pH]
 		 SBP and HR will be measured for every 3 min till the delivery of the baby and ABG will be taken as soon as possible. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="127" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/08/2021 
Date of Study Completion (India) 29/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Spinal anesthesia is the most commonly used anesthesia technique in caesarean section but it has many side effects like hypotension, bradycardia, nausea, vomiting. Incidence of hypotension and bradycardia in non-obstetric population is 33% and 13% but in obstetric population the incidence of post spinal hypotension is around 60%. (1) Using vasopressor has been highly recommended for routine prevention of post spinal hypotension during caesarean delivery. The commonly used vasopressor during caesarean delivery is phenylephrine but phenylephrine sometime causes maternal cardiac depression. (2) Nor adrenaline is another vasopressor characterized by alpha agonistic activity in addition to a weak beta agonistic activity so nor adrenaline is considered a vasopressor with less cardiac depression effect (3) along with this dexamethasone shown to reduce post spinal hypotension by blunting Bezold Jarish reflux and increasing peripheral vascular resistance. (4)
Parturients scheduled for caesarean section who will meet the inclusion criteria will be sensitized regarding the study using the patient information sheet [both in English and odia] during the pre-anesthesia check-up.

Patients will be randomly allocated into two groups using a computer-generated randomization chart to receive either intravenous dexamethasone 8mg (4) in the (Group A) and 2 ml normal saline in (group B) 15 minutes before spinal anesthesia. (9, 10)

In the operating room, standard ASA monitors will be attached (electrocardiography, pulse oximetry, non-invasive blood pressure monitor).

Then spinal anesthesia technique will be performed with the patient in the sitting position at L3-4 or L4-5 level with 0.5% hyperbaric bupivacaine 10 to 12mg + 20 mcg fentanyl. The drugs will be administered intrathecally after confirmation of free backflow of cerebrospinal fluid through a 25-gauge Quincke spinal needle. SBP and HR will be measured for every 3 min till the delivery of the baby.
References:

1. Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-                                  induced hypotension with ondansetron in parturients undergoing caesarean section: a double-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 hypotension during 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 during Caesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology.2019 ;130(1):55–62.

 

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


 
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