| CTRI Number |
CTRI/2020/09/027926 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of tablets of Pregabalin and Clonidine to give safer general anesthesia to patients during gall bladder removal operations. |
|
Scientific Title of Study
|
Oral Premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy : A comparative evaluation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department Of Anesthesiology and Critical Care , JNMCH, AMU |
| Address |
Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9570105618 |
| Fax |
|
| Email |
adi198713@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Kamran Habib |
| Designation |
Assistant Professor |
| Affiliation |
Department Of Anesthesiology and Critical Care , JNMCH, AMU |
| Address |
Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897172780 |
| Fax |
|
| Email |
syedkamranhabib@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Kumar |
| Designation |
Junior Resident |
| Affiliation |
Department Of Anesthesiology and Critical Care , JNMCH, AMU |
| Address |
Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9570105618 |
| Fax |
|
| Email |
adi198713@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India,Pin 202002 |
|
|
Primary Sponsor
|
| Name |
Department Of Anesthesiology and Critical Care JNMCH AMU |
| Address |
Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India Pin 202002 |
| Type of Sponsor |
Government 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 |
| aditya kumar |
Department Of Anesthesiology and Critical Care , JNMCH, AMU |
Department Of Anesthesiology and Critical Care , JNMCH, AMU,Aligarh,Uttar Pradesh, India Pin 202002
Aligarh
UTTAR PRADESH |
9570105618
adi198713@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: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glucose Tablets |
Changes On Hemodynamic Parameters After oral premedication with Glucose Tablets which is a Placebo drug acting as Control group |
| Intervention |
Pregabalin,Clonidine |
Changes on Hemodynamic Parameters after oral premedication with Pregabalin OR Clonidine Acting as Group 1 OR Group 2
Pregabalin - 75mg orally to be given 60 to 75 min before induction of anesthesia
Clonidine - 100mcg orally to be given 60 to 75 min before induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Prior Written informed consent.
Patients scheduled for Laparoscopic Cholecystectomy.
Patients with ASA grade 1 and 2.
|
|
| ExclusionCriteria |
| Details |
Patient refusal or Unco-operative patients
History of chronic pain/ neuropathy.
Patients with co-existing cardiac disease, asthma, severe renal or hepatic dysfunction.
Anticipated difficult intubation.
Hypersensitivity reaction.
Psychiatric and neurological diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the changes in heart rate, systolic, diastolic and mean systemic arterial blood pressure |
Before induction
After intubation1min,5min,10min
After creation of pneumoperitonium at 15min,30min,45min
10min after release of pneumoperitonium
10min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare post operative pain.
To assess the intra operative and post operative analgesic requirement.
To evaluate and compare post operative nausea and vomiting.
|
RSS at whendrug is given,1hour,2hours,4hours
VAS at 30min after extubation,60min after extubation,4hours after extubation, 8hours after extubation,12hours after extubation
POST OP NAUSEA/VOMITTING yes 0r no
RESCUE ANALGESIA yes 0r no |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/09/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
TITLE oral premedication with pregabalin or clonidine for hemodynamic stability during laryngoscopy and laparoscopic cholecystectomy , a comparitive evaluation INTRODUCTION laryngoscopy acts as noxious stimuli leading to increase in autonomic response , this pressor response may be life threatening for some patients so many anesthetic agents, analgesics, adjuvants have been used to blunt this response.this study has been designed to compare hemodynamic response to laryngoscopy during laparoscopic cholecystectomy between pregabalin, clonidine and a placebo given as premedication. HYPOTHESIS it is hypothesised that clonidine when given as premedication shows a better hemodynamic stability in patients as compared to pregabalin whereas pregabalin shows better analgesic and sedative propertives. |