| CTRI Number |
CTRI/2018/04/013244 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different doses of a drug for better comfort of patient during procedure to insert a tube inside their air passage |
|
Scientific Title of Study
|
Comparison of two different doses of dexmedetomidine on patient comfort and hemodynamic parameters during retrograde intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Walian |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of anesthesia, kgmu lucknow, India
Lucknow, Uttar pradesh, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
walian.ashish10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanmay Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anesthesia king georges medical university Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
tanmayanesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanmay Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anesthesia king georges medical university Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
tanmayanesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashish Walian
Department of anesthesia kgmu lucknow uttar pradesh india |
|
|
Primary Sponsor
|
| Name |
Ashish Walian |
| Address |
A503 gautam buddha hostel kgmu lucknow, india |
| 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 |
| Ashish Walian |
King Georges Medical University |
Department of anesthesia, kgmu, Lucknow, India
Lucknow
UTTAR PRADESH |
9411687061
walian.ashish10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with oral cavity cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine 1.5mcg/kg |
Dexmedetomidine in a dose of 1.5mcg/kg was given as intravenous infusion for 10min and then retrograde intubation was performed |
| Comparator Agent |
Dexmedetomidine 1mcg/kg |
Dexmedetomidine in a dose of 1mcg/kg was given as intravenous infusion for 10min and retrograde intubation was performed |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1- ASA class 1 and 2 patients
2- Mouth opening less then 2cm due to any pathology
3- MPG grade 3 and 4
4- Thyromental distance less then 4cm
5- Restricted cervical mobility due to bone and joint disorder |
|
| ExclusionCriteria |
| Details |
1- Patient not giving consent to participate in the study
2- Patient with nasal mass
3- Patient with hypersensitivity to drug under study
4- Patients with history of ischemic heart disease
5- Patients with baseline heart rate less then 50bpm
6- morbidly obese patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Heart rate
2 Systolic blood pressure
3 Diastolic blood pressure
4 Oxygen saturation
5 Observer assessment of sedation score |
Vitals were recorded every minute for 10min during dexmedetomidine infusion and at 0min 1min 5min 10min 15min during the intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Ease of intubation
2 Patient reaction to placement of guidewire and tracheal tube
3 Cough severity
4 patient tolerance to endotracheal tube
5 Intubation time
6 Recall of the procedure
7 Discomfort during the procedure |
At 1min, 5min, 10min, 15min of intubation and 24hours after surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2017 |
| Date of Study Completion (India) |
31/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective randomised double blinded study was undertaken in patients with anticipated difficult intubation. Two groups were taken Group A patient were given Dexmedetomidine iv infusion 1mcg/kg over 10min and Group B patients were given Dexmedetomidine iv infusion 1.5mcg/kg over 10min prior performing retrograde intubation and groups were compared in terms of haemodynamic parameters and patient comfort during the procedure. Patients hemodynamic parameters in terms of heart rate and blood pressure were significantly higher in group A as compared to group B and patients of group B were better sedated during the retrograde intubation as compared to grouqp A patients. In terms of secondary outcome patientsfrom group B demonstrated better results in terms of patient reaction to intubation cough severity, recall of procedure , discomfort during the procedure and use of ketofolas rescue therapy during the procedure as compared to group A. however in terms of ease of intubation, tolerance to endotracheal tube, intubating time and complications no significant difference was found between the two groups. In conclusion dexmedetomidine in a dose 1.5mcg/kg provide better intubating condition, hemodynamic stability, adequate sedation and patient comfort during retrograde intubation. |