| CTRI Number |
CTRI/2015/07/006053 [Registered on: 29/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
23/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare effects of two drugs dexmeditomidine and fentanyl on blood pressure, pulse and recovery from general anesthesia in patients undergoing Ear Nose or throat surgery. |
|
Scientific Title of Study
|
A randomizrd double blind clinical trial to compare dexmedetomidine with fentanyl as an anesthetic adjuvant in patients undergoing ENT surgery. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit kaushikbhai patel |
| Designation |
Second year resident doctor M.D ANESTHESIA |
| Affiliation |
Government medical college surat |
| Address |
7, Pushpakunj society, Dharoi colony Road, Visnagar
Surat
GUJARAT
384315
India |
| Phone |
7383672450 |
| Fax |
|
| Email |
dr.rohitpatel2403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Patel |
| Designation |
Additional Professor, Department of anesthesia, New civil hospital surat. |
| Affiliation |
Government medical college surat |
| Address |
29-B, Navchetan society, Opposite RTO, Athwa lines,surat
Gujarat.
Surat
GUJARAT
395001
India |
| Phone |
9925176299 |
| Fax |
|
| Email |
harshapad@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit kaushikbhai patel |
| Designation |
Second year resident doctor M.D ANESTHESIA |
| Affiliation |
Government medical college surat |
| Address |
7,Pushpakunj society, Dharoi colony road, Visnagar
Surat
GUJARAT
384315
India |
| Phone |
7383672450 |
| Fax |
|
| Email |
dr.rohitpatel2403@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rohit Kaushikbhai Patel |
| Address |
7,Pushpakunj society, Dharoi colony road,
Visnagar-384315 |
| Type of Sponsor |
Other [Principal Investigator Himself is a Primary Sponsor] |
|
|
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 Rohit Kaushikbhai Patel |
New Civil Hospital Surat |
Second floor Operation theater number 6, E.N.T OT, New Civil hospital Surat, majura gate, Surat-395001
Surat
GUJARAT |
7383672450
dr.rohitpatel2403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Govt Medical college and New civil hospital Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Class 1&2 patients scheduled for elective ENT surgeries., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP D (DEXMEDITOMIDINE) |
Bolus dose of dexmeditomidine 1 micrograms/kg body weight i.v over 10 minutes followed by infusion of dexmeditomidine 0.6 micrograms/kg/hr. |
| Comparator Agent |
GROUP F (FENTANYL) |
Bolus dose of fentanyl 2 micrograms/kg body weight i.v over 10 minutes followed by infusion of fentanyl 1 micrograms/kg/hr. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) ASA class 1&2 scheduled for elective surgeries.
B) age between 18 & 60 years.
C) no history of alcohol or drug abuse.
D) not received any opioid analgesic or alpha 2 agonist 24 hours prior to surgery. |
|
| ExclusionCriteria |
| Details |
A)history of allergy to alpha agonist or sulpha drug.
B)pregnant, lactating mothers and morbidly obese patients.
C)heart block.
D)presence of clinically significant neurologic, cardiac,renal,hepatic,gastrointestinal endocrine disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study and compare the effects of dexmedetomidine with fentanyl for
1) The sympatholytic effects & intraoperative hemodynamics.
2) Reduction in intraoperative propofol requirement.
3) The recovery variables. |
Heamodynamics parameters observed intraoperatively and recovery variables during extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic sparing effects and postoperative nausea and vomiting of dexmedetomidine with fentanyl. |
Secondary outcome observed after extubation for one hour. |
|
|
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)
|
31/10/2014 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, active control trial comparing dexmedetomidine with fantanyl as an anesthetic adjuvants in patients undergoing ENT surgery. The study will be conducted to compare the sympatholytic effects and intraoperative hemodynamics and recovery parameters of dexmedetomidine with fentanyl. Both group will receive study drug bolus infusion (Dexmed group 1microgram/kg, Fentanyl group 2microgram/kg)(over 10 minutes followed by maintenance dose (Dexmed group 0.6microgram/kg/hr, Fentanyl group 1microgram/kg/hr)infusion. Patient will be induced with injection propofol 2-3 mg/kg i.v and rocuronium 0.9 mg/kg I.v. Patient will be maintain on oxygen, nitrous oxide, vecuronium intermittently and propofol infusion(75microgram/kg/min). The hemodynamic parameters and recovery variables Will be recorded at specific time interval. |