| CTRI Number |
CTRI/2020/06/025712 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
06/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparison of Oral Pregabalin and Clonidine in modifying Blood pressure changes during Intubation in Laparoscopic Surgeries |
|
Scientific Title of Study
|
Comparative Study Of Oral Pregabalin And Clonidine For Attenuation Of Hemodynamic Responses To Laryngoscopy And Tracheal Intubation In Patients Undergoing 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 |
Jobitta R |
| Designation |
Junior resident (Postgraduate) |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Anesthesiology
Father Muller Medical College
Kanakanady
Mangaluru
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
08242238000 |
| Fax |
|
| Email |
jobittarobinson@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Harshavardhan K |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Anaesthesiology,
Father Muller Medical College,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9980124362 |
| Fax |
|
| Email |
harshaomega@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Harshavardhan K |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Anaesthesiology,
Father Muller Medical College,
Kankanady,
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9980124362 |
| Fax |
|
| Email |
harshaomega@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College
Kankanady
Mangaluru
Dakshina Kannada 575002 |
|
|
Primary Sponsor
|
| Name |
Father Muller Medical College |
| Address |
Kankanady
Mangaluru
Dakshina Kannada 575002 |
| Type of Sponsor |
Private 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 HARSHAVARDHAN K |
Father Muller Medical College |
Department of Anesthesiology,
Hospital Campus
Dakshina Kannada
KARNATAKA |
9980124362
harshaomega@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Medical College 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
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1
Body weight : 40 to 80 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of hypotension during laryngoscopy |
Baseline, At induction, 1minute after intubation, 3minutes after intubation, 5minutes after intubation, 10minutes after intubation, 15minutes after intubation, 30minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Variations in Blood Pressure during Laryngoscopy and Tracheal Intubation |
aseline, At induction, 1minute after intubation, 3minutes after intubation, 5minutes after intubation, 10minutes after intubation, 15minutes after intubation, 30minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
10/06/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is aimed at comparing oral pregabalin and clonidine in reducing pressor response which is normally seen during laryngoscopy and endotracheal intubation. |