| CTRI Number |
CTRI/2024/12/077529 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
A Study to see if patients remember anything during anaesthesia for procedures when they are not breathing on their own |
|
Scientific Title of Study
|
Incidence of awareness during general anaesthesia in procedures using the apnoeic oxygenation technique : A prospective observational study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4547_Protocol Version 1.1 dated 5 October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayana Amin |
| Designation |
Professor |
| Affiliation |
Tata memorial centre |
| Address |
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai-400012.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Amin |
| Designation |
Professor |
| Affiliation |
Tata memorial centre |
| Address |
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai-400012.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaitra Pednekar |
| Designation |
Junior Resident |
| Affiliation |
Tata memorial centre |
| Address |
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai-400012.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9702202338 |
| Fax |
|
| Email |
chaitrapednekar63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai-400012. |
|
|
Primary Sponsor
|
| Name |
Tata memorial centre |
| Address |
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai-400012. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayana Amin |
Tata Memorial Hospital |
Department of Anesthesia Critical care and Pain, Second floor, Main Building Mumbai
Mumbai
MAHARASHTRA |
9820742327
drnayana.amin@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital_Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with age 18 years or more.
2)ASA grade 3 or less.
3)Patients with normal neurological status.
4)Procedures such as direct laryngoscopy, micro laryngoscopy, triple scopy,
micro laryngoscopy with laser. |
|
| ExclusionCriteria |
| Details |
1)Patients with age less than 18 years.
2)Refusal of consent by patient.
3)Procedures requiring upfront endotracheal intubation.
4)Procedures not requiring apnoeic oxygenation.
5)Patients who are not neurologically sound.
6)Patient requiring transfer to ICU after procedure.
|
|
|
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 general anaesthesia in procedures in which apnoeic oxygenation is employed.
|
within 3 hours of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess factors associated with awareness during general anaesthesia |
within 3 hours of intervention |
|
|
Target Sample Size
|
Total Sample Size="310"
Sample Size from India="310"
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)
|
16/12/2024 |
| 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="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
|
Accidental Awareness under General Anaesthesia (AAGA) is a serious but preventable
complication that can lead to long term potential psychological consequences such as anxiety,
depression, PTSD. Intraoperative awareness is characterized by intraoperative
consciousness and postoperative recall of events. Patients may experience auditory recalls,
recall of disastrous experience of hurtful surgical stimulation. In scenarios where
neuromuscular blockade is used patients may experience a feeling of suffocation , paralysis
which is new and deeply distressing for the patient .
Patients undergoing procedures requiring apnoeic oxygenation techniques may be prone to
AAGA . This is due to the use of neuromuscular blockade which blinds the practitioner to the
most reliable indicator of insufficient anaesthesia as the patient cannot move in response to
painful stimulus Also, in such procedures there is a rapid pace from induction to procedural
stimulation.
There are various methods to assess AAGA such as monitors like BP, heart rate, bispectral
index, end tidal anaesthetic concentration , but none have been found to be totally efficacious
in detecting awareness under anaesthesia. Incidence of AAGA was found out to be more
when patients were specifically queried about it , in contrast to surveys which relied on
retrospective reviews of patient initiated reports. In this study we aim to find the incidence of awareness under anaesthesia when apnoeic
oxygenation techniques were employed for procedures and to analyze the factors associated
with the same. |