| CTRI Number |
CTRI/2025/10/095591 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Other |
|
Public Title of Study
|
How clinical pharmacists help prevent problems during surgery for patients with high blood pressure |
|
Scientific Title of Study
|
Impact of clinical pharmacist on perioperative complications in hypertensive patients
subjected to general anesthesia hospital based prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Revanasiddappa Devarinti |
| Designation |
Assistant Professor |
| Affiliation |
KLE college of pharmacy |
| Address |
Department of Pharmacy Practice Room No 15
KLE College of Pharmacy Nehru Nagar Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8886042417 |
| Fax |
|
| Email |
Siddu3pharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Revana siddappa Devarinti |
| Designation |
Assistant Professor |
| Affiliation |
KLE college of pharmacy |
| Address |
Department of Pharmacy Practice Room No 15
KLE College of Pharmacy Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8886042417 |
| Fax |
|
| Email |
Siddu3pharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachita Ashtekar |
| Designation |
Intern |
| Affiliation |
KLE college of pharmacy |
| Address |
Department of Pharmacy Practice Room No 13
KLE College of Pharmacy Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7349489098 |
| Fax |
|
| Email |
ashtekarrachita581@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
KLE college of pharmacy |
| Address |
Nehru nagar Belgavi Karnataka 590010 |
| Type of Sponsor |
Research institution |
|
|
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 Revanasiddappa Devarinti |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
Nehru Nagar Belgavi 590010
Belgaum
KARNATAKA |
8886042417
Siddu3pharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| klecopbgm ethics committee |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Clinical Pharmacist Intervention |
Group B is managed without clinical pharmacist intervention usual medication administration is performed by standard nursing and anesthesiology protocols, with no specialized pharmacy involvement. |
| Intervention |
Clinical Pharmacist Intervetion |
In Group A the clinical pharmacist provides medication adherence support ensures appropriate drug administration (that is right does given by the physician , at right time ,route which will be oral, right indication), monitors blood pressure during pre, intra, and postoperative phases, and assesses medication errors using NCC MERP and ASHP classification.
The pharmacist led intervention includes documentation, reporting, and outcome analysis specific to antihypertensive medication management, aiming to decrease drug-related complications and errors. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults from 18 years and above
Both female and female patients undergoing elective surgeries under general anesthesia
On one or more antihypertensive drugs. |
|
| ExclusionCriteria |
| Details |
Emergency surgeries
ICU bound or hemodynamically unstable patients
Patients refusing consent or unable to participate
Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Appropriateness of perioperative antihypertensive drug administration |
1 hour before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of perioperative hypotension and hypertension complications
Medication error rate
Drug related problems
Interventions by clinical pharmacist and acceptance rate |
4 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/11/2025 |
| 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 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
|
This research project is about seeing how having a clinical pharmacist involved in surgery care helps patients with high blood pressure have safer surgeries and fewer problems. The study looks at patients with high blood pressure who are having planned (not emergency) surgeries. Some patients receive special care from a pharmacist, while others follow the usual care without extra input from a pharmacist The main objective of the study is People with high blood pressure often face extra risks during surgery, such as changes in blood pressure that can cause complications. By involving a pharmacist, the team hopes to better manage medications, keep blood pressure stable, prevent errors, and improve recovery after surgery . How the Study Works The study is done in a hospital setting with two groups one group gets pharmacist care and one does not. The pharmacist helps by checking medications, making sure medicines are given correctly, and watching for problems. Blood pressure and medicine use are watched closely before, during, and after surgery for all patients What the Study Tries to Show If having a pharmacist helps prevent medicine mistakes and keeps patients safer during surgery. Whether pharmacist involvement leads to less up-and-down in blood pressure and fewer complications. The study also asks health care providers if they’re satisfied with having a pharmacist on the team. Overall, the goal is to see if teamwork including a pharmacist can make surgery safer for people with high blood pressure.
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