| CTRI Number |
CTRI/2021/10/037333 [Registered on: 14/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare oral clonidine versus oral pregabalin in patients undergoing laproscopic surgery |
|
Scientific Title of Study
|
A Comparative evaluation of oral clonidine versus oral pregabalin premedication for attenuation of pressor response during, laryngoscopy , intubation and pneumoperitoneum in patients in laparoscopic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathvika Pati |
| Designation |
Junior Resident |
| Affiliation |
Dr. DY Patil Medical College and Hospital, Pimpri |
| Address |
Department of Anaesthesia, DY Patil medical college, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7795446246 |
| Fax |
|
| Email |
sathvikareddy009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHHAYA SURYAWANSHI |
| Designation |
Professor |
| Affiliation |
Dr. DY Patil Medical College and Hospital, Pimpri |
| Address |
Department of anaesthesia, DY Patil medical college, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sathvika Pati |
| Designation |
Junior Resident |
| Affiliation |
Dr. DY Patil Medical College and Hospital, Pimpri |
| Address |
DY Patil medical college, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7795446246 |
| Fax |
|
| Email |
sathvikareddy009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Dy patil medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sathvika Pati |
| Address |
Dy patil medical college, pune |
| Type of Sponsor |
Other [ other] |
|
|
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 Sathvika Pati |
Dr DY Patil Medical College, Hospital and Research centre |
High tech OT complex; High tech building,
Dr DY Patil Medical College, pimpri
Pune
MAHARASHTRA |
7795446246
sathvikareddy009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
oral clonidine |
Oral clonidine 150mcg 1 hour before surgery for attenuation of pressor response |
| Comparator Agent |
Oral pregabalin |
oral pregabalin 150mg 1hr before surgery for attenuation of pressor response |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in age group of 18 to 60 years
2) Patients with ASA I and II
3) Hemodynamic stable patients
4) Patients posted for laparoscopic surgeries under general anesthesia
5) Patients willing to give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1) Patients with known case of diabetes, cardiac, respiratory and renal disease.
2) Patients with anticipated difficult intubation
3) Patients on prolong antihypertensive drugs, sedatives and hypnotic drugs
4) Patients with known allergy to any anesthetic medication
5) Obese patient
6) Patients with ASA>II
7) Lack of patient consent
. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To observe perioperative hemodynamic stability during laryngoscopy and laparoscopy.
|
30 minutes , 1hr after premedication,1 minute, 3minute after intubation, start of pneumoperitoneum, 15 min ,30 min after CO2 insufflation , 15min after release of CO2 insufflation , extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe postoperative analgesia requirement, sedation.and To observe any side effects. |
Immediately after surgery , 1hr after surgery
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2021 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sathvikareddy009@gmail.com].
- For how long will this data be available start date provided 05-08-2023 and end date provided 05-08-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
It is observational study where we compare Inj clonidine versus Inj pregabalin as a premedication for attenuation of pressor response in patients under general anaesthesia in laparoscopic surgery and To observe perioperative hemodynamic stability during laryngoscopy and laparoscopy; postoperative analgesia requirement, sedation and observe any side effects |