| CTRI Number |
CTRI/2020/03/023933 [Registered on: 12/03/2020] Trial Registered Prospectively |
| Last Modified On: |
10/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of orally given pregabalin and clonidine in reducing the blood pressure and heart rate response to laryngoscopy and endotracheal intubation in patients undergoing thyroid surgeries |
|
Scientific Title of Study
|
Comparison of oral Pregabalin with Clonidine for attenuating pressor response to direct Laryngoscopy in patients undergoing thyroidectomy-A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sruthy Victor |
| Designation |
PG resident |
| Affiliation |
MOSC medical college, KOlenchery |
| Address |
West hill road 2 Gossaikunnu,
Kuriachira PO
Thrissur
Kerala
PG resident
Dept of Anesthesia
MOSC Medical College
Kolenchery
Ernakulam
kerala
Ernakulam
KERALA
680006
India |
| Phone |
9400468075 |
| Fax |
|
| Email |
sruthyvictor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sam Phillip |
| Designation |
Professor,Dept of Anesthesiology |
| Affiliation |
MOSC medical college, Kolenchery |
| Address |
Dept of Anesthesiology
MOSC medical college
Kolenchery
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sam Phillip |
| Designation |
Professor,Dept of Anesthesiology |
| Affiliation |
MOSC medical college, Kolenchery |
| Address |
Dept of anesthesiology
MOSC medical college
Kolenchery
Ernakulam
Ernakulam
KERALA
682311
India |
| Phone |
9447209010 |
| Fax |
|
| Email |
drsam_p@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College
Kolenchery, Ernakulam |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College Kolenchery |
| Address |
MOSC Medical College
Kolenchery Ernakulam
Kerala |
| 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 SAM PHILLIP |
MOSC Medical College Kolenchery |
Department of Anesthesiology
Ernakulam
KERALA |
9447209010
drsam_p@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,MOSC medical college kolenchery |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLONIDINE |
TAB CLONIDINE 150 MCG ORALLY 1 HOUR PRIOR TO INDUCTION OF GENERAL ANESTHESIA, Single dose |
| Intervention |
PREGABALIN |
TAB PREGABALIN 150 MG ORAL 1 HOUR BEFORE INDUCTION OF GENERAL ANESTHESIA, Single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II PATIENTS WITH BMI 18 TO 30 UNDERGOING THYROIDECTOMY UNDER GENERAL ANESTHESIA |
|
| ExclusionCriteria |
| Details |
KNOWN ALLERGY TO STUDY DRUGS
THYROID WITH RETROSTERNAL EXTENSION
PATIENT REFUSAL FOR PARTICIPATION IN THE STUDY
PATIENTS ON LONG TERM TREATMENT WITH ANALGESICS SEDATIVES BETA BLOCKERS AND ANTICONVULSANTS
PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare oral Pregabalin with Clonidine in blunting the pressor response to direct laryngoscopy and endotracheal intubation by monitoring the changes in heart rate and blood pressure
|
1;3;5;7;10 minutes after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of oral pregabalin and clonidine on preoperative anxiety and sedation using standard scoring systems.
|
5 minutes before starting the case
|
| To evaluate the intra operative hemodynamic profile by monitoring heart rate, blood pressure and postoperative analgesia |
30 minutes interval for 6 hours 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)
|
20/03/2020 |
| 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="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)?
|
|
Brief Summary
|
Direct laryngoscopy and tracheal intubation are employed as gold standard for conduct of safe general anaesthesia for thyroidectomy surgeries. But both these procedures are noxious stimuli leading to hemodynamic fluctuations , higher myocardial oxygen demend , increased catecholamines and cardiac arrythmias. This is a concern in all patients particularly in cardiac and cerebrovascular diseases. Several techniques are employed to prevent the hemodynamic responses following laryngoscopy and intubation such as deepening the plain of anesthesia,use of vasodilators, lignocaine, betablockers calcium channel blockers and opiods. All these agents have various side effects.if no specific measures are taken , heart rate can increase from 26 to 66 percentage depending on the method of intubation and systemic blood pressure can increase from 36 to 45 percentage which maybe due to variation in balance between sympathetic and parasympathetic outflow or receptor hypersensitivity. Clonidine posses several properties to make it a valuable premedicant to attenuate the hemodynamic response of laryngoscopy and tracheal intubation. Pregabalin is a voltage gated calcium channel inhibitor with analgesic , anxiolytic and anticonvulsant properties making it a useful oral premedicant. Hence,we are conducting the present double blinded , randomised controlled trial to evaluate the effectiveness of oral pregabalin to clonidine in attenuating hemodynamic changes during direct laryngoscopy and tracheal intubation. , |