| CTRI Number |
CTRI/2013/07/003820 [Registered on: 18/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
17/07/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effect of dexmedetomidine during general surgery |
|
Scientific Title of Study
|
Clinical evaluation of dexmedetomidine on haemodynamic stress response during laryngoscopy and intubation-a randomized, double blind, parallel group, placebo controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveen Kumar Gour |
| Designation |
Resident Doctor |
| Affiliation |
Govt.Medical College,Bhavnagar |
| Address |
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat,364001
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat,364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825636161 |
| Fax |
|
| Email |
drgour2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Komal S Shah |
| Designation |
Associate Professor |
| Affiliation |
Govt.Medical College,Bhavnagar |
| Address |
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat,364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215252 |
| Fax |
|
| Email |
shah.komal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naveen Kumar Gour |
| Designation |
Resident Doctor |
| Affiliation |
Govt.Medical College,Bhavnagar |
| Address |
Room No.24,Dhanvantary PG Hostel No.1,Sir T.Hospital Campus,Bhavnagar,Gujarat
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825636161 |
| Fax |
|
| Email |
drgour2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board,
Govt. Medical College Bhavnagar,Gujarat |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology |
| Address |
Dept.of Anaesthesiology, Govt.Medical College,Bhavnagar,Gujarat |
| 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 |
| DrNaveen Kumar Gour |
Sir T.Hospital,Bhavnagar,Gujarat |
Dept. of Anaesthesioiogy,Jail Road, Bhavnagar.Gujarat,India-364001
Bhavnagar
GUJARAT |
9825636161
drgour2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
endotracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Dexmedetomidine |
As pre-medication,1mcg/kg in 100 ml normal saline intravenous infusion over 15-20 minutes,30 minutes before induction.Blood pressure,heart rate,oxygen saturation are recorded starting from baseline to infusion and then upto 30 minutes after intubation. |
| Comparator Agent |
placebo |
100 ml Normal saline intravenous infusion over 15-20 minutes,30 minutes before induction. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
-ASA physical status I and II.
-BMI ≤ 25kg/m2.
-Informed written consent for participation in study.
|
|
| ExclusionCriteria |
| Details |
-Patients with diabetes, renal disease, cardiac diseases like IHD, Hypertension.
-Patients on drugs, having effects on heart rate and blood pressure (sedatives, opioids, β blockers, calcium channel blockers) and anti-psychiatric drugs.
-Pregnant women and lactating mothers.
-Anticipated difficult intubation.
-Intubation attempt lasting longer than 20 seconds.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blunting in haemodynamic stress response during laryngoscopy and intubation. |
Blood pressure,heart rate,oxygen saturation are recorded starting from baseline to infusion and then upto 30 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedative effect after infusion. |
Sedation score will be recorded baseline and then after infusion of drug till induction. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
26/07/2012 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pressure response to laryngoscopy and intubation, resulting in stimulation of sympathetic nervous system leads to tachycardia and hypertension.Elevated plasma concentration of catecholamines due to sympathetic discharge increases HR,BP and myocardial oxygen demand, which may lead to haemodynamic instability. This response may be blunted by benzodiezepins,beta-blockers,opioids,nitroglycerine,etc.Alpha2 receptor agonists may also be used for this purpose,with reducing the dose requirement of general anaesthetic agents. Dexmedetomidine is the selective and potent alpha2 agonist.
The aim of our study the effect of Dexmedetomidine on controlling the haemodynamic response to laryngoscopy and intubation. |