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CTRI Number  CTRI/2024/02/062416 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Post spinal hypotension in pregnant women with and without hypothyroidism undergoing Caesarean delivery  
Scientific Title of Study   A Study comparing post spinal hypotension between pregnant women with and without hypothyroidism undergoing caesarean delivery  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana A Bharadwaj 
Designation  Associate Professor 
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  8437373388  
Fax    
Email  archana.a.b16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana A Bharadwaj 
Designation  Associate Professor 
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad


KARNATAKA
580009
India 
Phone  8437373388  
Fax    
Email  archana.a.b16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana A Bharadwaj 
Designation  Associate Professor 
Affiliation  SDM College of Medical Sciences and Hospital, Dharwad 
Address  Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad


KARNATAKA
580009
India 
Phone  8437373388  
Fax    
Email  archana.a.b16@gmail.com  
 
Source of Monetary or Material Support  
SDMCMS and Hospital, Dharwad 
 
Primary Sponsor  
Name  DrArchana A Bharadwaj  
Address  Department of Anaesthesiology SDM College of Medical Sciences and Hospital, Dharwad Postal code 580009 
Type of Sponsor  Other [Self] 
 
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 Vishwajeet K  SDM College of Medical Sciences and Hospital, Dharwad  OR no. 2 and CSOT, Main OT complex, Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Sattur, Dharwad
Dharwad
KARNATAKA 
8147273130

vishwavkmath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM College of Medical Sciences and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E039||Hypothyroidism, unspecified, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Spinal anesthesia in overt hypothyroid patients   Spinal anesthesia will be given in pregnant patients with overt hypothyroidism scheduled for Caesarean section and BP and HR will be monitored for 30 min and noted down  
Comparator Agent  Spinal anesthesia in pregnant women without hypothyroidism   Spinal anesthesia will be given in normal pregnant patients scheduled for Caesarean section and BP and HR will be monitored for 30 min and noted down  
Intervention  Spinal anesthesia in sub clinical hypothyroidism   Spinal anesthesia will be given in pregnant patients with subclinical hypothyroidism scheduled for Caesarean section and BP and HR will be monitored for 30 min and noted down  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  ASA 2 and 3 
 
ExclusionCriteria 
Details  women with High Risk pregnancies
any contraindication to administration of Spinal Anaesthesia. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Systolic blood pressure, Diastolic Blood pressure, Mean arterial pressure, heart rate   Every 2 min till 30 min after induction of spinal anesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Anaesthesia to a parturient requires highest degree of care because the anaesthesiologist has to look after two individuals, the mother and foetus. 

 

Hypotension during spinal anesthesia for caesarean delivery can have detrimental effects on both mother and neonate. 

After spinal anesthesia, the following parameters have been found to be risk factors for hypotension: sensory height block, baby weight, duration between spinal induction and skin incision, baseline systolic blood pressure, and anesthetistexperience.  

 

These effects include decreased utero placental blood flow, impaired foetal oxygenation with asphyxial stress and foetal acidosis and maternal symptoms of low cardiac output such as nausea, vomiting, dizziness and decreased consciousness.  

 

Careful positioning with left uterine displacement and volume preloading with crystalloids or colloids has been used to prevent it, but these are not complete measures and vasopressor is required to correct hypotension .

Hypothyroidism has been known to be associated with diastolic hypertension. hypothyroid patients have significantly increased diastolic blood pressure. Restoration of euthyroidism with thyroxine administration significantly reduces the systolic and diastolic blood pressures in these patients.

Clinical manifestations of hypothyroidism affecting anaestheticmanagement are reversible myocardial dysfunction, reversible defects in hypoxic and hyper carbic ventilatory drives, obstructive sleep apnoea, paraesthesia, increased cerebrospinal fluid protein concentration, hyponatremia, anaemia, abnormal coagulation profile, increased peripheral nociceptive thresholds and coronary artery disease.

Decreased intravascular volume, preload, cardiac output and blunted baroreceptor response make the patient sensitive to cardio depressant effects of General anaesthetics.

Regional anaesthesia is favoured over general anaesthesiaHypothyroidism is associated with qualitative platelet dysfunction, epidural hematoma is a theoretical risk and presence of normal coagulation is confirmed before regional anaesthesia

In this study we observe whether Hypothyroidism contributes to excessive post spinal hypotension in caesarean sections and also the requirement of vasopressor drugs in its management.

Elective surgery: T. Ranitidine 150 mg PO and T. Metaclopramide 10 mg PO with sips of water 2 hrs before surgery.

Emergency surgery: Inj. Ranitidine 50 mg IV and Inj. Metaclopramide 10 mg IV 30 min before surgery.


In the operation theatre appropriate equipment for airway management and emergency drugs are kept ready. Patients will be shifted to the operation theatre. The horizontal position of the operating table checked. 

The patients are made to lie supine with a pillow under head. 

Monitors - non invasive sphygmomanometer, ECG and pulse oximetry monitor. 

Intravenous access - 18 G IV cannula. Ringer lactate solution started at 15ml/kg

 

The anaesthesiologist unaware of the patient’s history will perform the subarachnoid block and note the observations in all the patients involved in the study. 

Patients are placed in right lateral position. 

Skin over the back was prepared with antiseptic solution and draped with sterile towel. 

The L3-L4 interspace will be identified and 26 G Quincke-Babcock needle isintroduced in this space through a midline approach. 

Once the needle pierced the dura and is in the subarachnoid space, free flow of CSF is verified and 10 mg (2ml) of 0.5% Heavy Bupivacaine +  100 mcg of Morphine(0.1 ml) is administered intrathecally. The patients are turned supine and immediately a wedge is placed under the right flank. 

Oxygen is administered at a rate of 6 lit/min by a face mask. 

Inj. Oxytocin 3 U in 5% Dextrose is given over 30 seconds after clamping the cord. Successive doses are repeated every 3 minutes as required. Intravenous fluids were administered at a rate of   ml / hr throughout the surgery. 

Heart rate, Systolic BP, Diastolic BP, MAP and SPO2 are recorded and taken as baseline value. The same parameters are monitored every minute till 30 mins and thereafter every 5 minutes till the end of surgery. 

Whenever Hypotension (Fall in Systolic BP < 20 % from baseline value or systolic BP < 90 mm Hg) occurred Vasopressor bolus of Inj Phenylephrine 25mcg will be given 

The time of onset of hypotension after SAB, lowest systolic BP recorded, total no. Of boluses and total mg of vasopressor used are recorded. 

Bradycardia (HR < 60 / min) is noted and is treated with Inj. Atropine 0.3 mg IV bolus. 

The highest level of sensory block is assessed by pinprick method 5 min after SAB. 

The subarachnoid block-delivery interval will be recorded. 

Neonatal outcome is assessed by the paediatrician by APGAR score at first and fifth min. 

The incidence of nausea and vomiting is noted. 

Total intravenous fluids given and urine output is also noted.

 
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