CTRI Number |
CTRI/2012/08/002858 [Registered on: 06/08/2012] Trial Registered Prospectively |
Last Modified On: |
28/01/2016 |
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
|
Study to assess the usefulness of a new drug, Dexmedetomidine, for sedation of patients during insertion of a tube in the wind pipe using endoscopy before anaesthesia |
Scientific Title of Study
|
To study the effectiveness of “Dexmedetomidine†for sedation in elective awake fibre-optic intubation |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
1032 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
JV Divatia |
Designation |
Professor and Head, Department of Anaesthesia, Critical Care and Pain |
Affiliation |
Tata Memorial Hopsital |
Address |
Dr. E. Borges Marg
Parel
Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
jdivatia@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Konineeka Das |
Designation |
Junior Resident |
Affiliation |
Tata Memorial Hopsital |
Address |
Dr. E. Borges Marg
Parel
Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
ckd7582@gmail.com |
|
Details of Contact Person Public Query
|
Name |
JV Divatia |
Designation |
|
Affiliation |
Tata Memorial Hopsital |
Address |
Dr. E. Borges Marg
Parel
Mumbai
Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
jdivatia@yahoo.com |
|
Source of Monetary or Material Support
|
Institutional, Tata Memorial Hospital |
|
Primary Sponsor
|
Name |
Tata Memorial Hospital |
Address |
Dr. E. Borges Marg
Parel
Mumbai 400012 |
Type of Sponsor |
Research institution and hospital |
|
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 |
JV Divatia |
Department of Anaesthesia, Tata Memorial Hospital |
Dr. E. Borges Marg
Parel
Mumbai 400012 Mumbai MAHARASHTRA |
9869077435
jdivatia@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Tata Memorial Hospital IRB II |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients requiring awake fibreoptic intubation prior to induction of general anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dexmedetomidine |
single intravenous loading dose of Dexmedetomidine 1.0mcg/kg over 10 mins |
Comparator Agent |
Placebo |
intravenous 0.9% sodium chloride for injection in volume similar to that of dexmedetomidine over 10 minutes |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1)Patients undergoing major head and neck surgeries scheduled for an elective nasal awake fibreoptic intubation due to an anticipated difficult airway
2)ASA Physical Status I-II. |
|
ExclusionCriteria |
Details |
1)Pregnant or lactating females
2)Use of an α-2-adrenoreceptor agonist or antagonist within 14 days
3)Use of an opiod administered orally or intravenously within 1 hr or intramuscularly within 4 hrs
4)Presence of increased intracranial pressure or CSF leak
5)Acute alcohol intoxication
6)Uncontrolled seizure disorder
7)History of acute unstable angina
8)Laboratory in acute MI within past 6wks
9)Heart rate 50 beats per minute
10)Systolic blood pressure 90mmhg
11)Complete heart block unless patient had a pacemaker
12)Liver transaminase level 2 times the upper normal limit.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Ease of intubation:(acceptable score 3 to 6; not acceptable 6): median score and no. of patients
2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale ≥2 throughout the study.
3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2)
4)Patient cooperation (no. of patients with a score of 1)
|
Till completion of fibreoptic intubation and induction of general anaesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)Mean dose of Midazolam required and number of patients in each group requiring resuce midazolam
2)Haemodynamic instability
3)Anaesthesiologist’s assessment of ease of patient care (either easy or not easy)
4)Recall of anxiety, pain and the procedure itself during the AFOI. |
upto 24 hours after the procedure |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
06/08/2012 |
Date of Study Completion (India) |
Date Missing |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways. Obtaining optimal intubating conditions when providing patient comfort and safety are the major goals while preparing the patient for fibreoptic intubation. One challenge associated with this procedure is to provide adequate sedation while maintaining a patent airway and ensuring ventilation. An ideal sedation regimen would provide patient comfort, blunting of airway reflexes, patient cooperation, haemodynamic stability, amnesia and the maintenance of a patent airway with spontaneous ventilation. Conventional sedatives like the benzodiazepines, propofol, or opiates have respiratory-depressant properties that may be detrimental in tenuous airway situations.
Dexmedetomidine is a drug whose clinical profile makes it especially well suited for sedation during awake fibreoptic intubation. It is a highly specific α2-agonist that can produce sedation, anxiolysis, analgesia, and profound levels of sedation in the absence of respiratory depression. The latter property is of special interest in difficult airway cases because during dexmedetomidine administration a stable respiratory pattern is usually seen, with little or no deterioration in respiratory pattern or change in oxygenation.
This study is specifically conducted to determine whether a loading dose of i.v. dexmedetomidine before awake fibre-optic intubation for patients with difficult airway undergoing General Anaesthesia will provide greater ease of intubation and better patient tolerability, adequate sedation without respiratory depression and upper airway obstruction and reduced haemodynamic responses as compared to placebo. Rescue sedation will be given in both groups in case of anxiety, agitation or discomfort. |