| CTRI Number |
CTRI/2021/10/037256 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison Of Nebulisation With Dexmedetomidine And Nebulisation With 4% Lignocaine Plus Dexmedetomidine For Awake Fibreoptic Intubation |
|
Scientific Title of Study
|
A Comparative Evaluation Of Efficacy Of Nebulisation With Dexmedetomidine And Nebulisation With 4% Lignocaine Plus Dexmedetomidine For Awake Fibreoptic Intubation In Difficult Airway Scenario: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Kumar |
| Designation |
Additional Professor |
| Affiliation |
IGIMS,PATNA |
| Address |
Department of Anaesthesiology and Critical care medicine,IGIMS,Patna-800014
Patna
BIHAR
800014
India |
| Phone |
8789655581 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Additional Professor |
| Affiliation |
IGIMS,PATNA |
| Address |
Department of Anaesthesiology and Critical care medicine,IGIMS,Patna-800014
BIHAR
800014
India |
| Phone |
8789655581 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Additional Professor |
| Affiliation |
IGIMS,PATNA |
| Address |
Department of Anaesthesiology and Critical care medicine,IGIMS,Patna-800014
BIHAR
800014
India |
| Phone |
8789655581 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA-14 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi institute of medical sciences |
| Address |
DEPT OF ANAESTHESIOLOGY,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA-14 |
| 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 Arvind Kumar |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA |
OT complex, Department of Anaesthesiology and critical care, IGIMS, Patna
Patna
BIHAR |
8789655581
arvind007kumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine hydrochloride |
The study will be conducted on 80 patients with difficult airway (LEMON 2),randomly allocated in 2 groups of 40 each. Group D will be nebulized with 2mcg/kg of Dexmedetomidine hydrochloride ( to a total volume of 4 ml using 0.9% normal saline) and Group LD will be nebulized with 2mcg/kg of dexmedetomidine hydrochloride+2ml of 4% lignocaine hydrochloride ( to a total volume of 4 ml using 0.9% normal saline) . After checking preanesthetic report, consent, identity, and fasting, the patients will be explained about the awake Fiberoptic guided intubation during the preoperative assessment. Inside the operating room after securing an intravenous (i.v ) line ,injection ondansetron 4mg i.v and injection glycopyrrolate 0.2mg i.v. will be given. Nasal xylometazoline drops (2 in each nostril,two times at a gap of 10 min)will be instilled. Inside the operating room, electrocardiography(ECG), non invasive blood pressure (NIBP),pulse oximetry (SPO2)and end tidal carbon dioxide (EtCO2)will be applied for monitoring. An OMRON Ultrasonic NE-U17 nebulizer with the oxygen flow rate of 6-8 L/min will be used to deliver the drugs in naso-oro-pharynx in both the Groups. In the sitting position patients will be encouraged to inhale deeply through their nose and mouth to facilitate entrainment of nebulized drug into their airway over 10 min.Both groups will receive superior laryngeal nerve blocks with 2ml of 2% lignocaine on each side and transtracheal recurrent laryngeal nerve block with 2% loxicard(lignocaine hydrochloride without preservative) . Four puffs of 10% lignocaine hydrochloride to oro-pharynx space will be given. Adequate effect of local anesthesia will be confirmed by heaviness in the oral cavity and by hoarseness of voice.
Fiber optic intubation will then be performed.
STATISTICAL ANALYSIS Randomization is done by computer-generated random number tables. Chi-square test and unpaired t-test will be used for statistical analysis . |
| Intervention |
Dexmedetomidine hydrochloride with lignocaine hydrochloride |
The study will be conducted on 80 patients with difficult airway (LEMON 2),randomly allocated in 2 groups of 40 each. Group D will be nebulized with 2mcg/kg of Dexmedetomidine hydrochloride ( to a total volume of 4 ml using 0.9% normal saline) and Group LD will be nebulized with 2mcg/kg of dexmedetomidine hydrochloride+2ml of 4% lignocaine hydrochloride ( to a total volume of 4 ml using 0.9% normal saline) . After checking preanesthetic report, consent, identity, and fasting, the patients will be explained about the awake Fiberoptic guided intubation during the preoperative assessment. Inside the operating room after securing an intravenous (i.v ) line ,injection ondansetron 4mg i.v and injection glycopyrrolate 0.2mg i.v. will be given. Nasal xylometazoline drops (2 in each nostril,two times at a gap of 10 min)will be instilled. Inside the operating room, electrocardiography(ECG), non invasive blood pressure (NIBP),pulse oximetry (SPO2)and end tidal carbon dioxide (EtCO2)will be applied for monitoring. An OMRON Ultrasonic NE-U17 nebulizer with the oxygen flow rate of 6-8 L/min will be used to deliver the drugs in naso-oro-pharynx in both the Groups. In the sitting position patients will be encouraged to inhale deeply through their nose and mouth to facilitate entrainment of nebulized drug into their airway over 10 min.Both groups will receive superior laryngeal nerve blocks with 2ml of 2% lignocaine on each side and transtracheal recurrent laryngeal nerve block with 2% loxicard(lignocaine hydrochloride without preservative) . Four puffs of 10% lignocaine hydrochloride to oro-pharynx space will be given. Adequate effect of local anesthesia will be confirmed by heaviness in the oral cavity and by hoarseness of voice.
Fiber optic intubation will then be performed.
STATISTICAL ANALYSIS Randomization is done by computer-generated random number tables. Chi-square test and unpaired t-test will be used for statistical analysis . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient consent, ASA grade 1 and 2, patient with anticipated difficult intubation(LEMON >2), BMI >30 kg/m2 |
|
| ExclusionCriteria |
| Details |
patient refusal, airway hypersensitivity, allergy to drugs used (lignocaine/dexmedetomidine),epileptic patients,patients with poor cardiopulmonary reserve, bleeding tendency, obesity, other co-morbid conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.sedation/alertness(OAA SCORE)
2.vocal cord movement(%)
3.limb movement
4.fibreoptic intubation score
5.coughing |
0 to 5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the hemodynamic changes of two groups
2) Dose sparing effect of propofol |
0 min,1 min, 2 min , 3 min, 4 min, 5 min |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/10/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
EFFICACY OF NEBULIZATION WITH DEXMEDETOMIDINE AND NEBULIZATION WITH 4% LIGNOCAINE PLUS DEXMEDETOMIDINE FOR AWAKE FIBEROPTIC INTUBATION IN DIFFICULT AIRWAY SCENARIO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A COMPARATIVE EVALUATION OF EFFICACY OF NEBULIZATION WITH DEXMEDETOMIDINE AND NEBULIZATION WITH 4% LIGNOCAINE PLUS DEXMEDETOMIDINE FOR AWAKE FIBEROPTIC INTUBATION IN DIFFICULT AIRWAY SCENARIO Different topical and regional techniques have been developed to subdue reflexes and facilitate awake fiberoptic intubation .It is essential to sufficiently anesthetize the upper airway and suppress the gag, swallow ,and cough reflexes prior to awake fiberoptic intubation and thus ensure patient comfort PRIMARY OBJECTIVES: A comparative double blinded randomised study will be performed- 1) To evaluate the effect of preoperative nebulisation with dexmedetomidine and preoperative nebulisation with dexmedetomidine plus lignocaine for awake fiberoptic intubation on- a) sedation/alertness b) vocal cord /limb movement c) coughing |