| CTRI Number |
CTRI/2025/02/081178 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study observing the drugs being prescribed to the patients undergoing surgery in department of general surgery at SMS hospital Jaipur |
|
Scientific Title of Study
|
A Descriptive Study on Drug Prescription Pattern
Among Preoperative and Postoperative Inpatients in
Department of General Surgery at SMS Hospital
Jaipur |
| 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 Ravindra Kumar Sharma |
| Designation |
Postgraduate Resident |
| Affiliation |
SMS Medical college and hospital Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
8005883421 |
| Fax |
|
| Email |
sharmaravindrakumar939@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chetna Meena |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
9414980943 |
| Fax |
|
| Email |
chetnamahak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chetna Meena |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
9414980943 |
| Fax |
|
| Email |
chetnamahak@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College, Jaipur, Rajasthan, India, 302004 |
|
|
Primary Sponsor
|
| Name |
Dr Ravindra Kumar Sharma |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur,Rajasthan, India 302004 |
| 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 |
| Dr Ravindra Kumar Sharma |
Inpatients ward, Department of general surgery, SMS Hospital,Jaipur, Rajasthan, India |
SMS Medical College and Attached Hospitals, JLN Marg, Jaipur, Rajasthan, India 302004 Jaipur RAJASTHAN |
8005883421
sharmaravindrakumar939@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and attached Hospitals |
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 |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who will admitted for surgical procedure at inpatients department of
general surgery during the study period .
2. Patients of either sex with an age of 18 years and above. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate or give written informed consent.
2. Pregnant and lactating females.
3. Patients who left against medical advice.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Average number of drugs per encounter[prescription]
2. Percentage of drugs prescribed with a generic name
3. Percentage of encounters with antibiotic prescribed
4. Percentage of encounters with injections prescribed
5. Percentage of drugs prescribed from Essential Drugs List (EDL)
|
At first encounter only |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="322" Sample Size from India="322"
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)
|
03/03/2025 |
| 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 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
|
The careful and judicious use of various drugs during the perioperative period can lead to a faster recovery post-major surgeries, minimizing complications, morbidity, mortality, and hospital stay duration. The use of evidence-based guidelines and collaboration among the surgical team, anaesthesia team, and nursing staff ensures optimal patient care. The anaesthesiologist acts as a vital link connecting the preoperative, intraoperative, and post-operative phases.Pre-anaesthetic medications are typically given to reduce the adverse effects of anaesthesia, facilitate the surgical process, and decrease the risk of post-operative complications. These medications include gastro protectives, sedatives, anticholinergic agents, antiemetics, and opioid analgesics. Surgery is performed using a variety of drugs, including inhaled, intravenous, and local anaesthetics, sedative-hypnotics, opioids, and neuromuscular blocking agents. Post-surgery, medications are prescribed to manage pain, prevent infections, control gastric secretion, and alleviate nausea and vomiting. According to the World Health Organization (WHO), drug utilization is defined as the “study of marketing, distribution, prescription, and uses of drugs in a society stressing on the resulting medical, social, and economic consequences”. Drug therapy is a crucial component of patient care management in healthcare settings. Numerous pharmaceutical products with various brand names are available to prescribers and consumers, often at high costs. The global issue of irrational and inappropriate drug use in healthcare systems is a significant concern. Therefore, the primary goal of drug utilization research is to promote the rational use of drugs in the population.
Rational drug use is also defined as "administering the right drug to the right patient at the right time in the right dose at the right price." Understanding the pattern of drug prescriptions and identifying irrational prescribing practices is essential for raising awareness among prescribers.
Regular drug utilization studies are necessary to enhance therapeutic efficacy, reduce adverse effects, and provide feedback to prescribers to ensure rational medicine use. Increasing awareness among doctors about essential drugs, the benefits of prescribing generic drugs, and the use of rational medicines is crucial. Antimicrobial agents (AMAs) are predominantly prescribed postoperatively, and their excessive use can lead to antimicrobial resistance. The World Health Organization (WHO) developed the Access, Watch, Reserve (AWaRe) classification to optimize the use of AMAs. This classification includes 87 AMAs in the Access group, 141 in the Watch group, 29 in the Reserve group, and 103 in the Not Recommended group. Moreover, there are limited studies that have comprehensively examined drug utilization patterns in surgical indoor postoperative patients. |