FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075417 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find association between anxiety before surgery(Caesarean section) and fall in blood pressure after spinal anaesthesia. 
Scientific Title of Study   Association Between Pre-Operative Anxiety and Post- Spinal Hypotension in Women Undergoing Elective Caesarean Section: A Cross-Sectional Study. 
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 Manoj Kumar J 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Anaesthesiology and Critical Care, 2nd floor institute block, Jawaharlal Institute of Postgraduate Medical Education and Research Campus, Gorimedu, Dhanvantari Nagar, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7010074804  
Fax    
Email  jmanojkumar11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M V S Satya Prakash  
Designation  Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Anaesthesiology and Critical Care, 2nd floor institute block, Jawaharlal Institute of Postgraduate Medical Education and Research Campus, Gorimedu, Dhanvantari Nagar, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9786184626  
Fax    
Email  munaganuri1975@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Kumar J 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  Department of Anaesthesiology and Critical Care, 2nd floor institute block, JIPMER Campus, Gorimedu, Dhanvantari Nagar, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7010074804  
Fax    
Email  jmanojkumar11@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education & Research (Intramural fund), admin block 1st floor, Jawaharlal Institute of Postgraduate Medical Education and Research Campus, Gorimedu, Dhanvantari Nagar, Pondicherry, India, 605006. 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education & Research 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
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 Manoj Kumar J  Jawaharlal Institute of Postgraduate Medical Education & Research  Department of Anaesthesiology and Critical Care, 2nd floor institute block, JIPMER Campus, Gorimedu, Dhanvantari Nagar, Pondicherry.
Pondicherry
PONDICHERRY 		 7010074804

jmanojkumar11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL Since it is an observational study  NIL Since it is an observational study 
Comparator Agent  NIL Since it is an observational study  NIL Since it is an observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All consenting parturients admitted at JIPMER for elective Caesarean section under spinal anaesthesia with American Society of Anaesthesiologist (ASA) status II and III
 
 
ExclusionCriteria 
Details  1. Uncontrolled systemic hypertension
2. Preeclampsia
3. Preexisting hypotension
4. Known case of psychiatric disorder on
regular medication
5. Any contraindication for spinal
anaesthesia
6. H/o alcoholism
7. Infection of salivary glands
8. K/c/o acute or chronic pancreatitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the level of preoperative anxiety in patients scheduled for elective Caesarean delivery.
 		 Preoperative period
that is one day before surgery or on the day of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To identify the association between pre-operative anxiety & blood pressure changes during spinal anaesthesia for elective Caesarean delivery.   Intra-operative period
that is on the day of surgery
time within the operation theatre 
 
Target Sample Size   Total Sample Size="272"
Sample Size from India="272" 
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)   01/01/2025 
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="2"
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   PRIMARY PURPOSE
       1.To assess the level of preoperative anxiety in patients scheduled for elective Caesarean delivery.
       2.To identify the association between pre-operative anxiety and blood pressure changes during spinal anaesthesia for elective Caesarean delivery.

STUDY HYPOTHESIS

       Hypotension after spinal anaesthesia is primarily  due  to  the  suppression  of  sympathetic outflow. Patients with a higher baseline sympathetic drive were seen to  have a profound fall in  blood pressure after spinal anaesthesia. Therefore it can be  rationalized  that  patients  with  higher  pre- operative anxiety may have a markedly significant post-spinal hypotension.

PROCEDURE

After obtaining approval from the Department Postgraduate Research Monitoring Committee  (PGRMC),  Institutional  Ethics  Committee,  this  study  will  be registered in Clinical Trials Registry-India (CTRI). Written informed consent will be obtained from patients after explaining the whole procedure, before the start of the study.

One day before or on the day of surgery, the pre-operative anxiety of the patient is assessed using four standard direct psychological measures of anxiety: 

1)  State-Trait Anxiety Inventory (STAI)

2)  Visual Analogue Scale For Anxiety Mood (VAS)


Indirect physical measure of anxiety using Salivary Amylase will also be done. Salivary sample will be collected using a hand-held monitor called Cocorometer from Nipro, Osaka, Japan. This device has a main monitor and test-strips which are sufficient to collect saliva. Saliva will be collected from the sublingual area in about 30 seconds using the test-strips.
The  baseline  blood  pressure  will  be  recorded  on  arrival  of  the  patient  to  the operating theatre. A 18G/20G intravenous line is secured and 500 ml of Ringer’s Lactate  is  given  as  pre-load/co  load  before  the  administration  of  spinal anaesthesia. Spinal anaesthesia will be administered in the left lateral position, at the level of L4–L5 or L5–S1 intervertebral space using 1.8 to 2ml (depending on the height of the patient) of 0.5% hyperbaric bupivacaine. After administration the patient is immediately placed in supine position with a wedge under the right hip. Surgery will be allowed to begin when the sensory level of block is at least T4 level bilaterally. 

Maternal blood pressure will be measured during the intra-operative period using Non-invasive Blood Pressure (NIBP) monitor. All measurements will be made in the supine position with left uterine displacement using wedge at right hip. Blood pressure will be measured at baseline, immediately before spinal anaesthesia, and every  minute  after  spinal  anaesthesia  until  delivery  and  every  5  mins  until completion of surgery.

Systolic Blood Pressure (SBP) below 100 mm Hg will be treated with a fluid bolus of 250–500 ml. SBP below 90 mm Hg will be treated with I.V. vasopressors (mephentermine/phenylephrine) depending on maternal heart rate.  


 
Close