| CTRI Number |
CTRI/2025/06/088987 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study on the Role of Pre-Anaesthetic Tests in the Care of Patients Having Surgery Under Anaesthesia at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Role of preanaesthetic investigations as a part of preanaesthesia assessment in perioprative management of patients undergoing any surgical procedure under anaesthesia at tertiary care centre-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 |
Dr Bhumika Pathak |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college |
| Address |
Room No 112, Department of Anaesthesiology, HM Patel institute of medical care and education, Shree krishna hospital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhumika Pathak |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college |
| Address |
Room No 112, Department of Anaesthesiology, HM Patel institute of medical care and education, Shree krishna hospital, Karamsad
GUJARAT
388325
India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushbu Shambhubhai Balar |
| Designation |
Second year resident Anaesthesiology |
| Affiliation |
Pramukhswami medical college |
| Address |
Room No 112, Department of Anaesthesiology, HM Patel institute of medical care and education, Shree krishna hospital, Karamsad
Anand
GUJARAT
388325
India |
| Phone |
8758724525 |
| Fax |
|
| Email |
balarkhushbu99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Krishna hospital, Pramukh swami medical college,Karamsad-388325, Anand, Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Shree Krishna hospital |
| Address |
Shree Krishna hospital,Pramukh swami medical college, Karamsad-388325, Anand, Gujarat,India |
| Type of Sponsor |
Private medical college |
|
|
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 Bhumika Pathak |
Shree Krishna Hospital Pramukh Swami Medical College Karamsad Anand Gujarat |
112,Department of anesthesiology,Pramukh swami medical college,Karamsad-388325, Anand Gujarat
Anand
GUJARAT |
9904438877
docbhum29@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand,Gujarat-388325 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing any surgery or invasive procedures under anaesthesia in shree krishna hospital |
|
| ExclusionCriteria |
| Details |
No exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the preanesthetic investigations advised for elective and emergency surgeries under anaesthesia. |
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of preanesthetic investigations on peri operative management and complications during surgery. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/07/2025 |
| 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 Yet Recruiting |
| 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
|
This observational study aims to evaluate the pattern and clinical relevance of preanesthetic investigations advised for patients undergoing elective and emergency surgeries at a tertiary care center Despite the existence of international guidelines preoperative investigation practices vary widely due to demographic socioeconomic and medicolegal factors
The study intends to assess which investigations are advised by anaesthesiologists compare them with those ordered by surgical departments determine their impact on perioperative management and complications and identify unnecessary tests and their implications on cost resource use and patient care
By analyzing data from patient records and hospital databases the study seeks to support protocol based patient specific testing potentially leading to cost effective safer and more efficient preoperative care The findings aim to contribute to institutional guidelines and optimize resource use in perioperative settings |