CTRI Number |
CTRI/2025/04/085439 [Registered on: 23/04/2025] Trial Registered Prospectively |
Last Modified On: |
21/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
A survey amongst Indian anaesthesiologists regarding Glucagon-Like Peptide-1 Receptor Agonists |
Scientific Title of Study
|
Perioperative Management of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists - A Survey of Knowledge and Current Practices Among Indian Anesthesiologists |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sohini Ray |
Designation |
Assistant Professor |
Affiliation |
KPC Medical College and Hospital Jadavpur |
Address |
Department of Anaesthesiology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur Kolkata
Kolkata WEST BENGAL 700032 India |
Phone |
9620885670 |
Fax |
|
Email |
drsohini.anaes@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sohini Ray |
Designation |
Assistant Professor |
Affiliation |
KPC Medical College and Hospital Jadavpur |
Address |
Department of Anaesthesiology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur Kolkata
Kolkata WEST BENGAL 700032 India |
Phone |
9620885670 |
Fax |
|
Email |
drsohini.anaes@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sohini Ray |
Designation |
Assistant Professor |
Affiliation |
KPC Medical College and Hospital Jadavpur |
Address |
Department of Anaesthesiology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur Kolkata
Kolkata WEST BENGAL 700032 India |
Phone |
9620885670 |
Fax |
|
Email |
drsohini.anaes@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
KPC Medical College and Hospital Jadavpur |
Address |
1F, Raja S C Mullick Road
Jadavpur
Kolkata-700032
West Bengal |
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 Sohini Ray |
KPC Medical College and Hospital Jadavpur |
Department of Anaesthesiology, KPC Medical College and Hospital,
Second floor, Block 3
1F, Raja S C Mullick Road
Jadavpur
Kolkata -700032 Kolkata WEST BENGAL |
9620885670
drsohini.anaes@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, KPCMCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
NIL |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
24.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Qualified Indian anaesthesiologists (DA, MD, DNB) working in India
2.Anaesthesiology Trainees pursuing DA/ MD/ DNB in India with more than 1 year experience in anaesthesiology. |
|
ExclusionCriteria |
Details |
1.Qualified Indian anaesthesiologists (DA, MD, DNB) working outside India.
2.Anaesthesiology Trainees pursuing DA/ MD/ DNB in India with less than 1 year experience in anaesthesiology.
3.Indian Doctors who have specialised in subjects other than anaesthesiology
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the knowledge and current practices of Indian anesthesiologists regarding the perioperative management of patients taking GLP-1 RAs. |
NA |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To assess the proportion of knowledge among Indian anaesthesiologists pertaining to management of patients taking GLP-1 RA in the perioperative period. |
NA |
2.To assess the current practices among Indian anaesthesiologists pertaining to management of patients taking GLP-1 RA in the perioperative period. |
NA |
3.To identify factors associated with knowledge & current practices among Indian anaesthesiologists regarding the management of patients taking GLP-1 RA in the perioperative period. |
NA |
|
Target Sample Size
|
Total Sample Size="144" Sample Size from India="144"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="148" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/05/2025 |
Date of Study Completion (India) |
05/08/2025 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsohini.anaes@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
The prevalence of type 2 diabetes mellitus (T2 DM) and obesity is rapidly increasing worldwide, including in India. Glucagon Like peptide-1 receptor agonists (GLP-1 RAs) have emerged as a cornerstone of pharmacological therapy for T2 DM, offering effective glycemic control and additional benefits such as weight reduction and cardiovascular risk mitigation. As a result of its efficacy in weight reduction, GLP-1 RA are now being used for weight loss in obese patients to avoid the need for bariatric surgery. As more patients start taking these drugs, their use will become increasingly common in patients presenting for surgical procedures. GLP-1 RAs exert their therapeutic effects by mimicking the endogenous GLP-1 hormone, which stimulates insulin secretion, suppresses glucagon release, and slows gastric emptying. While these actions are beneficial for glycemic control, they pose unique challenges in the perioperative period. Delayed gastric emptying, a prominent effect of GLP-1 RAs, increases the risk of pulmonary aspiration, particularly in patients undergoing general anaesthesia. Furthermore, the insulinotropic effects of these agents can lead to hypoglycemia, especially in the context of perioperative fasting and stress. Recognizing these potential complications, several professional organizations, including the American Society of Anesthesiologists (ASA) and the Australian and New Zealand College of Anaesthetists (ANZCA) have published guidelines regarding the perioperative management of patients taking GLP-1 RAs. These guidelines generally recommend withholding short-acting GLP-1 RAs on the day of surgery and withholding long-acting GLP-1 RAs for a longer period before surgery. However, the optimal management strategy remains debatable, and adherence to these guidelines in clinical practice is not uniformly established. Guidelines recommend development of multidisciplinary protocols individualised with patient risk. The safe use of GLP-1RA should include efforts to minimise the aspiration risk due to delayed gastric emptying. This can be achieved by preoperative diet modification and/or altering anaesthesia plan to consider rapid sequence induction of general anaesthesia for tracheal intubation. In India, where the prevalence of obesity and T2 DM is exceptionally high, the perioperative management of patients taking GLP-1 RA is of paramount importance. At present, Semaglutide and Tirzepatide are not available in India. However, over time these drugs will become more popular amongst people struggling with weight loss and Indian anaesthesiologists will encounter these patients when they come for surgical procedures. Variations in clinical practice, access to resources, and awareness of international guidelines may influence the perioperative management of these patients. At present, there is a paucity of data regarding the level of knowledge and current practices of Indian anesthesiologists in this area. Understanding the current practices and identifying potential knowledge gaps among Indian anesthesiologists is crucial for improving patient safety and avoiding complications. This study aims to address this critical knowledge gap by conducting a national survey of Indian anesthesiologists to assess their current knowledge and practices regarding the perioperative management of patients taking GLP-1 RAs. The findings of this study will provide valuable insights into the current state of practice in India and inform the development of evidence-based strategies to optimize perioperative care for this growing patient population. By evaluating the awareness and application of existing guidelines, this research will contribute to the enhancement of patient safety and the promotion of standardized, best-practice approaches within the Indian anesthesia community. |