| CTRI Number |
CTRI/2017/09/009876 [Registered on: 20/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of dexmedetomidine to attenuate pressor response during intubation. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF PROPOFOL AND PROPOFOL WITH DEXMEDETOMIDINE FOR ATTENUATION OF PRESSOR RESPONSE DURING LARYNGOSCOPY AND INTUBATION. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh kumar singh |
| Designation |
Junior Resident Department of Anesthesia |
| Affiliation |
Nalanda Medical College and Hospital , Patna |
| Address |
Junior Resident Anesthesia department
Nalanda Medical college and hospital,Agamkuan Patna
Patna
BIHAR
800007
India |
| Phone |
8507358489 |
| Fax |
|
| Email |
kumardr.ashutosh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay kumar sinha |
| Designation |
Associate professor Department of Anesthesia |
| Affiliation |
Nalanda Medical College and Hospital , Patna |
| Address |
Department of Anesthesia
Nalanda Medical college and Hospital,Agamkuan Patna
Patna
BIHAR
800007
India |
| Phone |
9334338755 |
| Fax |
|
| Email |
vksinha04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashutosh kumar singh |
| Designation |
Junior Resident Department of Anesthesia |
| Affiliation |
Nalanda Medical College and Hospital , Patna |
| Address |
Junior Resident Anesthesia Department
Nalanda Medical college and hospital,Agamkuan Patna
Patna
BIHAR
800007
India |
| Phone |
8507358489 |
| Fax |
|
| Email |
kumardr.ashutosh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Nalanda Medical College and Hospital Patna |
|
|
Primary Sponsor
|
| Name |
Nalanda Medical College and Hospital Patna |
| Address |
Nalanda Medical College and Hospital , kankarbagh main road .Patna |
| 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 |
| Ashutosh Kumar Singh |
Nalanda Medical College and Hospital Patna |
Department of Anesthesia operation theatre building Nalanda Medical College and Hospital Agamkuan Patna
Patna
BIHAR |
8507358489
kumardr.ashutosh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nalanda Medical College Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R932||Abnormal findings on diagnostic imaging of liver and biliary tract, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine and propofol |
dexmedetomidine 1mcg/kg body wt in 100ml normal saline infused in 15 mins before induction and induction with propofol 2mg/kg body wt. |
| Comparator Agent |
propofol only |
100ml normal saline infused in 15 min before induction then induce with propofol 2 mg/kg body wt. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II scheduled for elective surgical procedures under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway management ,hiatus hernia, GERD, BMI>30, patients on antihypertensive drugs, patients on sedatives, hypnotics , and antidepressants, H/o cardiovascular, respiratory, hepatic , renal diseases, patients with ASA grades III & above , endocrine disease and malnourished will be excluded from study. |
|
|
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, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes observed in vital parameters. |
up to ten minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects |
during whole surgical time period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/12/2015 |
| Date of Study Completion (India) |
30/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Yildiz M, Tavlan A, Tuncer S, Reisli R, Yosunkaya A, Otelcioglu. Effect of dexmedetomidine on haemodynamic responses to laryngoscopy and intubation: perioperative haemodynamics and anaesthetic requirements. Drugs RD 2006;7(1):43-52 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. This procedure includes laryngoscopy and intubation, the procedure is associated with intense sympathetic activity and hemodynamic stress marked by tachycardia, hypertension and sweating. Herein lays the rationale to continue the quest for an anaesthetic technique where the cardiovascular response can be attenuated. Various non-pharmacological and pharmacological methods have been used to attenuate the hemodynamic response to laryngoscopy and endotracheal intubation. Pharmacological methods like use of inhalational anaesthetic , topical lidocaine, narcotics, beta-blockers, calcium channel blockers, vasodilators have been tried. But none of the above approach and agents have proved to be ideal.so our primary outcome to know pressor response with dexmedetomidine. |