| CTRI Number |
CTRI/2025/08/092327 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of two acid-reducing medicines , Vonoprazan and Pantoprazole in people with diabetes undergoing planned surgery. |
|
Scientific Title of Study
|
Effect of oral vonoprazan versus pantoprazole on gastric fluid properties in diabetic patients undergoing elective surgeries. |
| 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 Tejasvi Dalla |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7717236638 |
| Fax |
|
| Email |
tejasvidalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital 32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care Block D Level 5
GMCH Sector 32B
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Saroa |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care Block D Level 5
GMCH Sector 32B
Chandigarh
CHANDIGARH
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, GMCH, Chandigarh- 160030 , INDIA |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care, Block-D, Level-5,
GMCH, Sector 32-B, Chandigarh 160030 , INDIA |
| Type of Sponsor |
Government 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 Tejasvi Dalla |
Government Medical College and Hospital, Chandigarh |
Department of
Anaesthesia and
Intensive Care,
Block-D, Level-5,
GMCH, Sector 32-B,
Chandigarh,
Pin-160030
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
7717236638
tejasvidalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) Sector 32-B, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
gastric pH and gastric ultrasound |
Vonoprazan 20mg or Pantoprazole 40mg will be administered orally night before the surgery and 2 hours before induction. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Diagnosed with Type 2 Diabetes Mellitus.
• ASA physical status one to three
• Scheduled for elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
• History of gastrointestinal surgery.
• Known acid-peptic disorders or gastric motility disorders.
• Use of acid-suppressive therapy within 72 hours prior to surgery.
• Pregnancy or lactation.
• Obesity (BMI more than 35 kg per metre square)
• Known renal or hepatic dysfunction.
• Allergy to study drugs
• Patients already on PPI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The pH of gastric content will be recorded using pH meter in both the groups. |
Patients will be transferred to the post-anaesthesia care unit (PACU), where they will be monitored for the incidence of postoperative nausea and vomiting (PONV) at 1 hour, 6 hours,
and 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the gastric residual volume in both the study groups.
• To evaluate any drug-related adverse events of Vonoprazan & Pantoprazole.
• To study the incidence of postoperative nausea & vomiting upto 24 hours in the post-
operative period. |
Patients will be transferred to the post-anaesthesia care unit (PACU), where they will be
monitored for the incidence of postoperative nausea & vomiting (PONV) at 1 hour, 6 hours,
and 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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="6"
Days="7" |
|
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
|
Pulmonary aspiration of gastric contents remains a serious perioperative complication, particularly in high-risk groups such as diabetic patients with gastroparesis. Current pharmacological prophylaxis with proton pump inhibitors (PPIs) like pantoprazole has limitations including delayed onset and variable efficacy. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), offers faster and more potent acid suppression with a single dose. This prospective, randomized, double-blind, single-centre interventional study aims to compare the efficacy of oral vonoprazan (20 mg) versus oral pantoprazole (40 mg) in modifying gastric pH and residual gastric volume (RGV) in 64 adult diabetic patients undergoing elective surgeries under general anaesthesia. Primary outcome is gastric pH; secondary outcomes include RGV (assessed by ultrasound), adverse drug events, and incidence of postoperative nausea and vomiting. Gastric content will be aspirated intraoperatively and analysed for pH and volume. The findings aim to evaluate the role of vonoprazan as a potential alternative for aspiration prophylaxis in high-risk surgical patients. |