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CTRI Number  CTRI/2019/12/022321 [Registered on: 11/12/2019] Trial Registered Prospectively
Last Modified On: 11/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Incidence of hypotension after spinal anaesthesia in normotensive and preeclamptic women undergoing caesarean section 
Scientific Title of Study   Comparison of haemodynamic response and phenylephrine requirement following spinal anaesthesia in normotensive and preeclamptic women undergoing caesarean section: a prospective observational 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 Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of anesthesiology and critical care Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Umaid hospital Department of anesthesiology and critical care Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of anesthesiology and critical care Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Umaid hospital Department of anesthesiology and critical care Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yuvraj S 
Designation  Junior Resident 
Affiliation  Dr. S.N. medical collage Jodhpur 
Address  Department of anesthesiology and critical care Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Dr S N Medical Collage Jodhpur RAJASTHAN 342001 India
Jodhpur
RAJASTHAN
342001
India 
Phone    
Fax    
Email  sweetyuvi003@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College Jodhpur 
 
Primary Sponsor  
Name  Dr S N Medical College Jodhpur 
Address  Shastri nagar Jodhpur 
Type of Sponsor  Government medical college 
 
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 
DrGeeta Singariya  Umaid Hospital  Opration theatre complex, Umaid Hospital, Department of anaesthesiology and critical care, Jodhpur Jodhpur
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Healthy parturients  hyperbaric 0.5% bupivacaine 10 mg (2ml)intrathecally 
Comparator Agent  Preeclamptic parturients  hyperbaric 0.5% bupivacaine 10 mg (2ml) intrathecally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women of age group 18-35 years belonging to ASA grade 2
Body Mass Index (BMI) between 20-35 kg/m2 undergoing cesarean section under spinal anesthesia including healthy parturients
Preeclamptic parturients (systolic blood pressure of 140 mmHg or higher, or a diastolic blood pressure of 90 mmHg or higher, or both, associated with proteinuria > 3 g/24 hours).  
 
ExclusionCriteria 
Details  Patients refusal
Known hypersensitivity to local anaesthetics
Infection at the site of injection
History of bleeding disorders or patients on anticoagulants
Preterm pregnancies less than 34 weeks gestation, twin pregnancy; those with signs of imminent eclampsia
Patients with cardiac disease (like heart blocks, dysarrythmias), chronic hypertensives, diabetics, renal or other organ system disease which preclude choice of spinal anaesthesia
Anatomical abnormality of spine. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the haemodynamic response  End of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.The total doses of Phenylephrine
2.Neonatal outcome in terms of umbilical cord pH, APGAR score
3.Intraoperative side effects / complications
 
End of surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/12/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

Source of Data: The study will be conducted in Umaid hospital of Dr. S. N. Medical college and associated group of hospitals, Jodhpur after seeking clearance from institutional ethical committee and obtaining written, informed  consent from the patients.

Study design: Prospective Cohort Comparison

Study Period: 06 months 

PRE ANAESTHETIC EVALUATION

Every patient will be subjected to detailed history, thorough physical examination and systemic examination prior to the surgery. Basic demographic data like age, sex, height and weight will be recorded. Routine investigations such as hemoglobin, complete blood count, blood sugar, renal function test, liver function test, blood grouping, cross matching, bleeding time, clotting time, electrocardiography or any specific test will be asked for as per recent guidelines from all the patients. Patients will be explained in detail about the anaesthesia procedure. All the patients planned for elective procedure will be instructed for minimum 6 hours fasting before surgery.

METHOD

After shifting the patients to OT, standard monitoring will be instituited with oxygen saturation (SPO2), 5 lead electrocardiogram (ECG) and baseline parameters like heart rate (HR), systolic blood pressure ( SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), respiratory rate (RR), SPO2, and ECG will be monitored by using multi parameter monitor.

An 18 G cannula will be inserted in peripheral vein and preloading will be started with crystalloid solution with a dose 10 ml/kg administered over 15 minutes. All patients will be premedicated with Inj ranitidine 50 mg IV and Inj metoclopromide 10 mg IV. All patients in the preeclampsia group will received a 4 g loading dose of intravenous magnesium sulfate (MgSO4) followed by a 1 g/hour infusion for 24 hours for seizure prophylaxis. The IV fluids will be given with the patient in the supine position with a wedge placed under the right hip to obtain a 15° left uterine displacement.

The patient will be then placed in the sitting position, and spinal anesthesia will be administered using 25 gauge Quincke needle at L3-L4  or L4-L5  vertebral interspace using hyperbaric 0.5% bupivacaine 10 mg intrathecally. After free flow of cerebrospinal fluid and negative aspiration of blood, the drug will be injected slowly over 10 sec. Each patient will then placed in the supine position with a left lateral tilt of 15-20 degrees. The height of the sensory block will be assessed using a pinprick test, and a 10°-15° head down-tilt (Trendelenburg position) will initiated if a T4 sensory level  not achieved at 10 minutes after the spinal injection. The surgery will be started once a T10 sensory block will be achieved.

Oxygen will be supplemented by venti mask. The highest dermatomal level of sensory blockade, the time to reach this level, time to achieve total motor blockade, time of start of surgery, delivery of baby, neonatal weight, umbilical cord pH, duration of surgery, side effects or complications will be recorded.

HAEMODYNAMIC MONITORING

All parameters (SBP, DBP, MAP, HR, SPO2, RR, and ECG)  will be recorded before performing spinal anaesthesia and at 2 minute intervals for 30 minutes after the puncture, and then every 5 minutes until the end of the surgery.

Hypotension will be defined as more than a 30% decline in MAP below the baseline in both groups or SBP < 100 mmHg in healthy parturients. Any episode of hypotension will be treated with phenylephrine bolus (50µg).If hypotension persists after one minute, another bolus of phenylephrine will be given. If patient does not respond after 3 boluses, ephedrine 5mg will be given for subsequent treatment. The total amounts of IV administered fluid, and the total doses of phenylephrine and ephedrine will  recorded as well. The largest and lowest value of maternal hypotension and HR from the baseline will also recorded and compared.

Any episode of bradycardia (HR<50 beats/min) will be treated with Inj Atropine 0.6mg bolus. Hypotension associated with bradycardia will be treated using ephedrine from the start rather than phenylephrine. Number and duration of hypotension and total dose requirement of phenylephrine or ephedrine will be recorded.

Side effects like nausea, vomiting will be recorded and treated with Inj Ondansetron IV 4mg. The other study variables that will be included are demographic data; gestational age; spinal puncture to skin incision, skin incision to skin closure, and uterine incision to delivery intervals; the upper sensory level at 10 min after the spinal injection; umbilical cord pH.

 

  



 
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