| CTRI Number |
CTRI/2025/11/096948 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of medicines given before surgery (ranitidine and pantaprazole) to check how they affect stomach acid and fluid levels |
|
Scientific Title of Study
|
Comparision of inj. Ranitidine 50mg, Inj. Ranitidine 100mg, inj. Pantaprazole 40mg preoperatively in assessment of gastric volume and pH in elective cases |
| 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 Anil kumar verma |
| Designation |
Consultant |
| Affiliation |
GSVM medical college |
| Address |
Department of Anaesthesiology, LLRH, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9336107410 |
| Fax |
|
| Email |
anil_16021976@rediffmail.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ariba inam |
| Designation |
Junior resident |
| Affiliation |
GSVM medical college |
| Address |
Department of Anaesthesiology, LLRH, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9517580555 |
| Fax |
|
| Email |
aribainam1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil kumar verma |
| Designation |
Consultant |
| Affiliation |
GSVM medical college |
| Address |
Department of Anaesthesiology, LLRH, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9517580555 |
| Fax |
|
| Email |
anil_16021976@rediffmail.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia , LLRH , kanpur, 208002, Uttar Pradesh, INDIA |
|
|
Primary Sponsor
|
| Name |
GSVM MEDICAL COLLEGE |
| Address |
Swaroop Nagar, NH-91 (Kanpur – On Gol Chauraha near Hallet Hospital), Kanpur nagar, 208002, Uttar Pradesh, 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 Ariba Inam |
LLR hospital |
Department of anesthesia and critical care
Kanpur Nagar
UTTAR PRADESH |
9517580555
aribainam1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee gsvm medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z530||Procedure and treatment not carried out because of contraindication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Pantoprazole |
40mg iv 1hour and 2 hour before elective surgery |
| Comparator Agent |
Injection Ranitidine |
100mg iv 1 hour and 2 hour before elective surgery |
| Comparator Agent |
Injection Ranitidine |
50mg iv 1 hour and 2 hour before elective surgery |
| Comparator Agent |
Injection ranitidine 50mg,injection pantoprazole 40 mg, injection ranitidine 100mg |
Each drug will be compared with the other two groups to evaluate differences in gastric ph and volume |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing surgery under sedation or GA.
Pregnant females.
Refusal to participate. |
|
| ExclusionCriteria |
| Details |
Allergy and contraindication to pantaprazole and Ranitidine.
Pregnant women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of the drugs in reducing gastric volume and aspiration Risk |
Gastric volume will be assessed through usg at 1 hour and 2 hour after giving drug preoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in gastric volume |
Assessment at 1 hour & 2 hour preoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="0"
Months="6"
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 is a Randomised controlled trial conducted on 60 patients to compare inj. Ranitidine 50mg , inj Ranitidine 100mg , inj pantaprazole 40mg preoperatively in assessment of gastric volume and ph in elective cases . The study aims to evaluate the correlation between ultrasonographic assessment of gastric volume after administration of inj. Ranitidine 50mg, inj ranitidine 100mg, inj pantaprazole 40mg1 hour or 2 houn before induction. . Primary outcome of our study is to assess the efficacy of the drug in reducing gastric volume and preferred timing of injection for premedication |