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CTRI Number  CTRI/2019/05/019071 [Registered on: 13/05/2019] Trial Registered Prospectively
Last Modified On: 12/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective , longitudinal 
Study Design  Other 
Public Title of Study   To study the relation between anxiety and lowering of blood pressure in the patients after receiving injection in back for undergoing caesarean section. 
Scientific Title of Study   Correlation of preoperative anxiety and post spinal hypotension in patients undergoing caesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PRACHI MORE 
Designation  MD ANAESTHESIA JUNIOR RESIDENT 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22

Mumbai
MAHARASHTRA
400022
India 
Phone  9820938785  
Fax    
Email  prachimore1388@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DEEPTI KOTWANI 
Designation  ASSISTANT PROFESSOR 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22

Mumbai
MAHARASHTRA
400022
India 
Phone  9870135926  
Fax    
Email  drdeeptiagrawal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DEEPTI KOTWANI 
Designation  ASSISTANT PROFESSOR 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22

Mumbai
MAHARASHTRA
400022
India 
Phone  9870135926  
Fax    
Email  drdeeptiagrawal@gmail.com  
 
Source of Monetary or Material Support  
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
 
Primary Sponsor  
Name  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION, MUMBAI-22 
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 
Dr PRACHI MORE   LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION  WARD 12,LABOUR WARD AND OBSTETRICS THEATRE
Mumbai
MAHARASHTRA 
9820938785

prachimore1388@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All consenting pregnant patients above age of 18 years, posted for elective and emergency Caeserean section receiving spinal anaesthesia will be included for the study 
 
ExclusionCriteria 
Details  1) Patients with complicated pregnancy (abruptio placenta/ placenta praevia)
2) Patients having Preeclampsia
3) Patients with preexisting / gestational hypertension
4) Patients with anaemia (Hb<9)
5) Patients with heart, pulmonary, renal or liver disease
6) Patients with psychiatric disorders
7) Inadequate time for anxiety assessment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the correlation between preoperative anxiety and hypotension in patients undergoing Caesarean section under spinal anaesthesia.  Patients will be assessed at the following time intervals:
1) Baseline assessment
2) Before spinal anaesthesia
3) After spinal anaesthesia( 2mins, 4mins, 6mins, 8mins, 10mins, 15mins, 20mins, 25mins, 30mins) 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the difference in the need of vasopressors between the different anxiety groups.
2. To determine difference in the level of preoperative anxiety in the patients presenting for elective and emergency Caesarean section
 
Patients will be assessed at the following time intervals:
1) Baseline assessment
2) Before spinal anaesthesia
3) After spinal anaesthesia( 2mins, 4mins, 6mins, 8mins, 10mins, 15mins, 20mins, 25mins, 30mins) 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/05/2019 
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="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This observational prospective longitudinal study will be performed after approval from the institutional ethics committee. All the parturients satisfying the inclusion criteria will be included in our study. Written informed consent will be taken from the patients. Their preoperative anxiety scores will be assessed in the preoperative ward using two standard and validated Scales which measure anxiety: 
  1.Verbal Analogue Scale (VAS) anxiety –   Parturients will be asked to rank subjective anxiety on a VAS scale of 0 to 10; where 0 is no anxiety at all and 10 the worst anxiety imaginable. The VAS score obtained will be converted to ordinal data as under:
 â€VAS of0 to 3 à Low Anxiety
 â€VAS of 4 to 6 à Moderate Anxiety
 â€VAS of 7 to 10 à High Anxiety  

2.The Amsterdam Preoperative Anxiety and Information Scale (APAIS Scale)

                                                                       APAIS question        Not at all

   Extremely
 1. I am worried about the anaesthetic.              1          2               3               4               5
 2. The anaesthetic is on my mind continually.     
 3. I would like to know as much as possible about the anaesthetic.     
 4. I am worried about the procedure.     
 5. The procedure is on my mind continually.     
 6. I would like to know as much as possible about the procedure     




The questionnaire consists of two sub scales, both the Anxiety subscale and the Information Need scale. The instrument has 6 questions rated by the patient on a 5-point scale. The Anxiety Subset score (sum C = sum A + sum S) is calculated as the sum of anaesthesia anxiety (sum A =1+2 questions), sum of surgical anxiety (sum S = 4 + 5 questions) and the need for information score is the sum of items 3 and 6. Each statement in APAIS is rated on 5 point scale; 1 not at all; 2 somewhat; 3 moderately so; 4 very much so; 5 extremely. APAIS anxietyscores (sum C) = 4-9 à Low anxiety, 10-14 à Moderate anxiety 15-20 àhigh anxiety.   Base Line Haemodynamic parameters (Heart rate, systolic and diastolic blood pressure) will be noted following this anxiety score assessment. As our institutional practice, following explanation of procedure and written informed valid consent,standard anaesthesia practice is giving spinal anaesthesia in the sitting position using hyperbaric Bupivacaine. On achieving sensory level of T6, surgery is started. Patients with partial or inadequate sensory blockade or achieving sensory levels above T5 will be excluded from the study. In case of any Intraoperative Obstetric complications (like excessive Blood loss, postpartum haemorrhage etc.) the patient will be excluded from the study and the conduct of anaesthesia will follow the standard protocol. However, occurrence of such complications will be noted. Heart rate, Non invasive arterial blood pressure (NIBP) will be measured and recorded at baseline, before administrating spinal anaesthesia and every 2 minute after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes. Time of baby delivery will be noted. Fall in Systolic blood pressure (SBP) by >20 % below baseline will be considered as hypotension and will be treated as per discretion of the involved anaesthesiologist. Requirement of vasopressors and intravenous fluid boluses needed, will be noted. Parameters noted will be – 1.Demographic Data (Age, Height, Weight, Educational Status,Parity) 2.Previous exposure to surgery & anaesthesia 3.Pre-operative Anxiety Score (VAS & APAIs) (Appendix B) 4.Level of Spinal Block (Sensory) 5.Haemodynamic Parameters: Heart Rate, Systolic and Diastolic Blood Pressure, in the supine position at the following events ·On preoperative assessment (Baseline) ·In the operating room - on Table ·Following spinal anaesthesia after patient is made supine ·Every 2 minutes after spinal anaesthesia for first 10 minutes followed by every 5 minutes for next 30 minutes     6. Vasoressors requirement
 
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