To find out if patients remember anything when general anaesthesia is given for caesarean operation

Not yet recruiting

Conditions: Pregnant females undergoing caesarean section under general anaesthesia

Registration Number: CTRI/2018/04/013143

Lead Sponsor: Lokmanya Tilak Municipal medical college and general hospital

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 patientâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 300

Inclusion Criteria

1.Pregnant female who have undergone cesarean section under general anesthesia.
2.Patients who give consent.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. To find out a possible association between categories of CS(1-4) and awareness.	2. To find out a possible association with patientâ€™s demographic data namely age, weight, ASA (American society of anaesthesiologists) grading, socioeconomic status and level of education, in case there is awareness.

Trial Locations

Locations (1): Lokmanya Tilak Municipal Medical College and general hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College and general hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Shubhra Srivastava
Principal investigator
7905862969
shubhra1104@gmail.com