| CTRI Number |
CTRI/2025/03/083229 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| 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 different routes of dexmedetomidine administration in surgical anaesthesia for head and neck cancer patients |
|
Scientific Title of Study
|
A comparison of intravenous dexmedetomidine vs. nebulized dexmedetomidine for awake fiberoptic bronchoscope guided intubation in head and neck surgery: A prospective, double blind, randomized trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KUMAR ANAND |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences,Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7091164546 |
| Fax |
|
| Email |
heartwill.anand6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences,Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8709135297 |
| Fax |
|
| Email |
drkmukesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NITESH SINHA |
| Designation |
Assistant Professor |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences,Bariatu, Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
7860337418 |
| Fax |
|
| Email |
dr.niteshsinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Sciences, RIMS, Bariatu, Ranchi, Jharkhand |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand |
| 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 |
| Dr KUMAR ANAND |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
Department of Anaesthesiology, Oncology, Neurosurgery and ENT, RIMS, Bariatu, Ranchi, Jharkhand-834009
Ranchi
JHARKHAND |
7091164546
Heartwill.anand6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (2) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (3) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (4) ICD-10 Condition: C411||Malignant neoplasm of mandible, (5) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (6) ICD-10 Condition: C490||Malignant neoplasm of connective and soft tissue of head, face and neck, (7) ICD-10 Condition: D103||Benign neoplasm of other and unspecified parts of mouth, (8) ICD-10 Condition: D105||Benign neoplasm of other parts oforopharynx, (9) ICD-10 Condition: D119||Benign neoplasm of major salivarygland, unspecified, (10) ICD-10 Condition: D210||Benign neoplasm of connective andother soft tissue of head, face and neck, (11) ICD-10 Condition: S030||Dislocation of jaw, (12) ICD-10 Condition: S129||Fracture of neck, unspecified, (13) ICD-10 Condition: S026||Fracture of mandible, (14) ICD-10 Condition: O||Medical and Surgical, (15) ICD-10 Condition: O||Medical and Surgical, (16) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection dexmedetomidine |
I.V dexmedetomidine 1mcg/kg in 50ml NS + (nebulization with 4% lignocaine 2.5ml + normal saline made up to 5ml) |
| Intervention |
nebulized dexmedetomidine |
I.V normal saline 50ml + (nebulization with dexmedetomidine 1mcg/kg + 4% lignocaine 2.5ml made up to 5ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a)The patient giving written and informed consent for study.
b)Patient posted for elective head and neck surgeries requiring elective nasal intubation.
c)All those patients having anticipated difficult airway.
d)Patients with ASA grade I and II.
e)Male and female patients aged between 18-70 years.
|
|
| ExclusionCriteria |
| Details |
a) Patients having a clinical diagnosis of any systemic disease.
b) Patients with severe renal or hepatic impairment.
c) Patient having any intra oral mass.
d) Patients with history of alcohol or drug addiction.
e) Patient having any predisposition to intra oral bleeding.
f) Patients having allergy to the study drugs.
g) Patients with cognitive impairment or communication problem.
h) Patient requiring conversion from use of sedative to general anesthesia.
i) All pregnant and lactating females.
|
|
|
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 |
| To obtain 5-point intubation comfort score for assessing patient tolerance. |
At time points from point of insertion of bronchoscope till intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To compare hemodynamic variables and associated changes from intubation.
b) To compare time required for intubation from the point of insertion of fibreoptic bronchoscope to successful placement of ET tube.
c) To obtain patient satisfaction score after extubation regarding ease and comfort of awake intubation. |
Record hemodynamic variables before fiberoptic intubation at
a. drug loading dose
b. 2minutes
c. 4minutes
d. 6minutes
e. 8minutes
f. 10minutes
Record hemodynamic variables after fiberoptic intubation at
a. 2minutes
b. 4minutes
c. 6minutes
d. 8minutes
e. 10minutes
|
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
04/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Awake fiberoptic intubation is gold standard for anticipated difficult airway. Nebulized dexmedetomidine is speculated to have lesser adverse effects, easy to administer and better tolerated by patients. |