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CTRI Number  CTRI/2018/04/013143 [Registered on: 10/04/2018] Trial Registered Prospectively
Last Modified On: 06/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To find out if patients remember anything when general anaesthesia is given for caesarean operation 
Scientific Title of Study   Awareness during general anaesthesia for 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  Shubhra Srivastava 
Designation  Junior Resident  
Affiliation  Lokmanya Tilak Municipal Medical College and General Hospital 
Address  Room no 514, New OPD Building, Lokmanya Tilak Municipal Medical College and General Hospital, Dr Babasaheb Ambedkar Road,Sion West, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7905862969  
Fax    
Email  shubhra1104@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Devangi Parikh 
Designation  Associate Professor 
Affiliation  Lokmanya Tilak Municipal Medical College And General Hospital 
Address  Room no. 403, Department Of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai-400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9820471638  
Fax    
Email  sdevangi10@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devangi Parikh 
Designation  Associate Professor 
Affiliation  Lokmanya Tilak Municipal Medical College And General Hospital 
Address  room no 403, Department Of Anaesthesiology, Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai-400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9820471638  
Fax    
Email  sdevangi10@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  Dr Babasaheb Ambedkar Road,Sion West, Mumbai 
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 Shubhra Srivastava  Lokmanya Tilak Municipal Medical College and general hospital  Department Of Anaesthesiology,Lokmanya Tilak Municipal Medical College and general hospital, Sion, Mumbai 400022
Mumbai
MAHARASHTRA 		 7905862969

shubhra1104@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  Pregnant females undergoing caesarean section under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Pregnant female who have undergone cesarean section under general anesthesia.
2.Patients who give consent
 
 
ExclusionCriteria 
Details  1.Patients who are not extubated and shifted on mechanical ventilator.
2.Patients with fetal demise, either intraoperatively or postoperatively.
3.GA given after failed spinal
4.GA supplementation given for inadequate spinal anaesthesia.
5.Duration of surgery more than 90 min
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of awareness during GA in patients undergoing CS .  Patients will be interviewed at three time points.
1) Immediate post-operative period (4 hours post extubation).
2) At 24 hrs. AND
3) On day 3 post op.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find out a possible association between categories of CS(1-4) and awareness.
2. To find out a possible association with patient’s demographic data namely age, weight, ASA (American society of anaesthesiologists) grading, socioeconomic status and level of education, in case there is awareness.
3. To find out a possible association of awareness with time of surgery.
4. To find out incidence of dreams during anaesthesia

 		 Patients will be interviewed at three time points.
1) Immediate post-operative period (4 hours post extubation).
2) At 24 hrs. AND
3) On day 3 post op.
 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   16/04/2018 
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="6"
Days="2" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet publicated 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a Prospective, observational, single arm, non-comparative cohort study, with aim of determining the incidence of awareness during GA in patients undergoing CS .

Awareness during anaesthesia may occur despite apparently sound anaesthetic management. Patient undergoing caesarean section (CS) under general anaesthesia (GA) are at high risk for awareness in view of limitations in administering premedication in the form of benzodiazepines and opioids and limitations in dosages of induction agents in order to prevent fetal respiratory depression. Drugs like benzodiazepines and opioids are given after delivery of baby, predisposing these patients to recall of intraoperative events. The problem is further compounded if the patient requires emergency CS in view of maternal and fetal distress due to bleeding, non-progress of labour etc., which may mandate 100% oxygen till delivery with or without volatile anaesthetics. Therefore, we want to conduct a prospective observational study in obstetric patients to detect the incidence of awareness during GA in CS.

In post-operative period, awareness will be assessed in our sample patients using the modified Brice questionnaire which is the current gold standard for detecting awareness. Patients will be interviewed at three time points:Immediate post-operative period (4 hours post extubation), at 24 hrs and on day 3 post op. The questions included in the modified Brice questionnaire will be asked in the patient’s own language.

Modified Brice Questionnaire:

1.What is the last thing you remember before going to sleep?

2.What is the very next thing you remember after waking up?

3.Do you remember anything between going to sleep and waking up?

4.Did you dream during your procedure?

5.What was the worst thing about your procedure?

     In case of awareness, the following details will be sought:.

Perception (Touch/Auditory/Visual /Pain/Unable to breath/Feeling surgery without pain/ Sensation of breathing tube)

Motor function(Tried to move/Able to move)  

Mental reaction(Immediate understanding/Immediate anxiety/Delayed symptoms

     In case dreams are detected, then dreams were:(Pleasant/Disturbing/Indifferent)

Question 1 and 2 of the questionnaire, is mainly to orient the patient for the subsequent questions and diagnosis of awareness will not be made on those replies. For question number 3 and 4, if patient answers yes or not sure, then the details of the same will be sought. A probable diagnosis of awareness(YES or POSSIBLE) will be made. All such cases will be assessed in detail by a senior investigator and crossconfirmed and discussed with the concerned anaesthesia team, conducting the case. After that the  final diagnosis will be made. For question 5, answer will be relevant only if it is pertaining to intraoperative recall and will be handled in the same manner as above. If the reply points to preoperative, at extubation or postoperative events, the same will be regarded as irrelevant for detecting awareness. 

Awareness Classification[2]

1.       Awareness-yes: Definitive awareness will be considered as occurring when the patient is certain of having been aware at any time during the surgery.

2.       Awareness-possible: Awareness will be considered as possible in those cases where the patient thinks that she had been awake during surgery but was not completely sure. (If the patient is unable to recall any event definitely indicative of awareness, but memories can be related to intraoperative events, she will be categorized as possible awareness.)

    Awareness-no: When the patient is sure of having been asleep during surgery, she will be categorized as no awareness.

 
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