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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
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