| CTRI Number |
CTRI/2025/02/079843 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective questionnaire based observational study |
| Study Design |
Other |
|
Public Title of Study
|
To know about the patients overall satisfaction and experience after general anesthesia |
|
Scientific Title of Study
|
To Evaluate Patient Satis faction and Overall Experience
with General Anesthesia: an Observational 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 |
Ibrahim Saleem Mainaparambil |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8848479954 |
| Fax |
|
| Email |
ibrahimsaleem1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of anaesthesiology |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department of anaesthesiology |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Ibrahim Saleem Mainaparambil |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ibrahim Saleem Mainaparambil |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA |
8848479954
ibrahimsaleem1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I , II or III fit patients
2. All adults above 18 years
3. Patients able to read at least one language Marathi , Hindi or English
4. Patients posted for both elective and emergency surgeries
5. Availability of informed consent
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Patients with neurological deficits or psychiatric illness not able to comprehend.
3. Patients too unwell or confused to be able to complete the questionnaire
4. Obstetric and terminally ill patients
5. Patients who refused consent.
6. Patients with ASA physical status IV or more
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) anaesthesia associated discomfort
2) patient dissatisfaction
|
1st hour , 6th hour , 12th hour , 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
What is the last thing you remember before going to sleep
What is the first thing you remember after waking
Do you remember anything between going to sleep and waking up
Did you dream during your procedure
Were your dreams disturbing to you
What was the worst thing about your operation |
Post extubation |
|
|
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)
|
10/02/2025 |
| 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="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
|
AIM To evaluate patient satisfaction and overall experience with general anaesthesiaOBJECTIVES
• Monitoring the discomfort caused by the pain at the site of surgery and anaesthetic injection.
• Incidence of post operative nausea , vomiting , shivering and feeling cold
• Assess drowsiness, confusion/ disorientation post operatively
• Incidence of post operative thirst, hoarseness , sore throat
• Assess awareness under general anaesthesia
|