| CTRI Number |
CTRI/2021/02/030955 [Registered on: 03/02/2021] Trial Registered Prospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of two drug (clonidine vs midazolam-fantanyl) in anesthesia for varicose vein surgery and relation with COMT gene |
|
Scientific Title of Study
|
Comparison of clonidine vs midazolam-fentanyl in monitored anaesthesia care for varicose vein surgery and its correlation with pain modulating COMT gene |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manish Kumar |
| Designation |
junior resident |
| Affiliation |
king georges medical university , lucknow |
| Address |
KGMC Department of Anaesthesia LUCKNOW
KGMC Department of Anaesthesia LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8174888268 |
| Fax |
|
| Email |
drmanishsingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Gupta |
| Designation |
Professer |
| Affiliation |
king georges medical university , lucknow |
| Address |
KGMC Department of Anaesthesia LUCKNOW
KGMC Department of Anaesthesia LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839288980 |
| Fax |
|
| Email |
rgkgmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajni Gupta |
| Designation |
Professer |
| Affiliation |
king georges medical university , lucknow |
| Address |
KGMC Department of Anaesthesia LUCKNOW
KGMC Department of Anaesthesia LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839288980 |
| Fax |
|
| Email |
rgkgmu@gmail.com |
|
|
Source of Monetary or Material Support
|
| king georges medical college |
|
|
Primary Sponsor
|
| Name |
Dr Rajni Gupta |
| Address |
kGMC Department of Anaesthesia LUCKNOW |
| Type of Sponsor |
Other [self] |
|
|
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 Rajni Gupta |
king george medical college |
KGMU LUCKNOW , department of anaesthesia
Lucknow
UTTAR PRADESH |
9839288980
rgkgmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee KGMU lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I838||Varicose veins of lower extremities with other complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clonidine
midazolam-fantanyl |
clonidine 1mcg/kg bolus by clonidine i.v. infusion at 0.1mcg/kg/hr midazolam0.06mg/kg + fantanyl 1mcg/kg over 10 min followed by infusion i.v. .2ml/kg/hr |
| Comparator Agent |
clonidine,
midazolam and fantanyl |
clonidine 1mcg/kg bolus by clonidine i.v. infusion at 0.1mcg/kg/hr
midazolam0.06mg/kg + fantanyl 1mcg/kg over 10 min followed by infusion i.v. .2ml/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AGE BETWEEN 18YEARS TO 60 YEARS
ASA GRADE 1 & 2
DIAGNOSED CASE OF VARICOSE VEIN
PATIENT GIVING WRITTEN INFORMED CONSENT WILL BE TAKEN |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
PATIENT UNDERGONE GENERAL ANAESTHESIA WITH IN 7 DAYS, HAD TAKEN ALPHA-2 AGONIST WITH IN 14 DAYS
HEART BLOCK
PSYCHIATRIC DISORDER
ASA 3 & 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sedative and analgesic effect of clonidine vs midazolam-fentanyl in Monitored Anesthesia Care (MAC) during varicose vein surgery. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effects of the COMT gene on modulating pain and its association.
To assess the intra operative hemodynamic stability.
To assess the post-operative safety and efficacy .
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
09/02/2021 |
| 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="0"
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
|
THIS STUDY TO COMPARE THE EFFECTIVENESS, HAEMODYNAMIC CHANGES AND DURATION OF SEDATION AND ANALGESIA BETWEEN COMBINATION OF CLONIDINE AND MIDAZOLAM- FANTANYL IN MONITORED ANAESTHESIA CARE FOR VARICOSE VEIN SURGERY AND ITS CORRELATION WITH PAIN MODULATING COMT GENE . THIS IS A PROSPECTIVE RANDOMISED CONTROLLED STUDY . |