| CTRI Number |
CTRI/2010/091/003044 [Registered on: 09/12/2010] |
| Last Modified On: |
26/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical study to find whether dexmedetomidine provides adequate comfort to patients during awake nasal fibreoptic intubation |
|
Scientific Title of Study
|
Comparison of the safety and effectiveness of dexmedetomidine with a combination of midazolam and fentanyl for sedation during awake fibreoptic nasotracheal intubation - A prospective, randomized, double-blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha Shenoy |
| Designation |
|
| Affiliation |
|
| Address |
Additional Professor, Department of Anaesthesia
Not Applicable
N/A
576104
India |
| Phone |
0820 9880842121 |
| Fax |
|
| Email |
anitharshenoy@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh Goneppanavar |
| Designation |
|
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Associate Professor, Department of Anaesthesia
Not Applicable
N/A
576104
India |
| Phone |
0820 9480575663 |
| Fax |
|
| Email |
drumeshg@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Umesh Goneppanavar |
| Designation |
|
| Affiliation |
|
| Address |
Associate Professor, Department of Anaesthesia
Not Applicable
N/A
576104
India |
| Phone |
0820 9480575663 |
| Fax |
|
| Email |
drumeshg@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Anitha Shenoy |
| Address |
|
| Type of 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 |
| Umesh Goneppanavar |
Department of Anaesthesia, Kasturba Hospital, Manipal |
Associate Professor, Department of Anaesthesia,-576104
|
0820 9480575663
drumeshg@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, KMC, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients who are scheduled to undergo surgery and require awake nasal fibreoptic intubation in view of anticipated difficult oral intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine 1µg/kg administered intravenously over 10 minutes prior to attempting awake nasal fibreoptic intubation |
|
| Comparator Agent |
Fentanyl 1µg/kg administered intravenously and midazolam 1mg intravenous prior to attempting awake nasal fibreoptic intubation |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria : Patients of either gender aged above 18 years requiring awake nasal fibreoptic intubation
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patients with ASA physical status IV, raised intracranial pressure, uncontrolled seizure disorder / known psychiatric illness, receiving α2 agonists/antagonists in the past two weeks, where either dexmedetomidine or benzodiazepine administration is contra-indicated and patients with acute unstable angina, laboratory confirmed acute myocardial infarction within the past 6 weeks, heart rate <50bpm, systolic blood pressure <90 mmHg, or complete heart block unless they have a pacemaker, patients with elevated liver enzymes > 2 times normal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fibrescopy score
Intubation score
Post intubation score |
At end of visualisation of glottis
At point of intubation
At end of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for endoscopy and time for intubation
Ease of endoscopy and intubation
Number of attempts taken at endoscopy and intubation
Postoperative patient satisfaction score
|
At end of intubation process and 24 h after the surgical procedure |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/09/2010 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomized, double-blinded study comparing the safety and efficacy of dexmedetomidine administered at 1µg/kg over 10 min. This is compared with a control group that receives injection 1mg midazolam and fentanyl 1µg/kg. The study will be done in patients requiring awake nasal fibreoptic intubation in view of difficult airway. The primary outcome measures will be the scores observed during fibreoptic scopy, intubation and post intubation. |