| CTRI Number |
CTRI/2025/08/092336 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Making breathing tube placement easier: comparing two medicines and their mix used as a mist to help patients stay calm and comfortable when awake |
|
Scientific Title of Study
|
Effect of nebulization with lignocaine, dexmedetomidine and lignocaine with dexmedetomidine on degree of ease of fiber-optic intubation. |
| 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 Haresh S |
| Designation |
Junior Resident (Department of Anaesthesiology) |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9176618571 |
| Fax |
|
| Email |
drharesh1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9229983164 |
| Fax |
|
| Email |
1074vicky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelesh Nema |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh.
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9893427372 |
| Fax |
|
| Email |
neeleshnema@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh, India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi Medical College,Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh, India 462001 |
| 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 Haresh S |
Hamidia Hospital |
Operation Theatre No 1, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India - 462001
Bhopal
MADHYA PRADESH |
9176618571
drharesh1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Intervention |
4% Lignocaine 5ml |
Glycopyrrolate 0.2mg IM will be given 30 minutes before
surgery and two drops of 0.1% Xylometazoline will be
instilled in both the nostrils. Patients will be nebulized for
20 minutes with 5 ml 4% Lignocaine before intubation along with oxygenation with
nasal prongs at a flowrate of 4L/min. The route of administration is nebulisation (inhalation) via face mask using nebulizer and frequency is single time administration. The total duration of intervention is 20 minutes before intubation. Adequate local
anaesthesia will be confirmed by heaviness of the tongue
and dryness of posterior pharynx of patients. During fibreoptic intubation, 2ml lignocaine 4% will be
administered by spray-as-you-go technique. Fibreoptic
intubation will be performed by using flexible fibreoptic
bronchoscope preloaded with 7.5mm/7.0mm ET tubes for
males and females respectively. ET tube position will be
confirmed by auscultation and capnography. |
| Comparator Agent |
4% Lignocaine 5ml + Dexmedetomidine 2mcg/kg |
Glycopyrrolate 0.2mg IM will be given 30 minutes before surgery and two drops of 0.1% Xylometazoline will be instilled in both the nostrils. Patients will be nebulized for 20 minutes with 5ml 4% Lignocaine + Dexmedetomidine 2mcg/kg before intubation along with oxygenation with nasal prongs at a flowrate of 4L/min. The route of administration is nebulisation (inhalation) via face mask using nebulizer and frequency is single time administration. The total duration of intervention is 20 minutes before intubation. Adequate local anaesthesia will be confirmed by heaviness of the tongue and dryness of posterior pharynx of patients. During fibreoptic intubation, 2ml lignocaine 4% will be administered by spray-as-you-go technique. Fibreoptic intubation will be performed by using flexible fibreoptic bronchoscope preloaded with 7.5mm/7.0mm ET tubes for males and females respectively. ET tube position will be confirmed by auscultation and capnography. |
| Comparator Agent |
Dexmedetomidine 2mcg/kg |
Glycopyrrolate 0.2mg IM will be given 30 minutes before surgery and two drops of 0.1% Xylometazoline will be instilled in both the nostrils. Patients will be nebulized for 20 minutes with dexmedetomidine 2mcg/kg before intubation along with oxygenation with nasal prongs at a flowrate of 4L/min. The route of administration is nebulisation (inhalation) via face mask using nebulizer and frequency is single time administration. The total duration of intervention is 20 minutes before intubation. Adequate local anaesthesia will be confirmed by heaviness of the tongue and dryness of posterior pharynx of patients. During fibreoptic intubation, 2ml lignocaine 4% will be administered by spray-as-you-go technique. Fibreoptic intubation will be performed by using flexible fibreoptic bronchoscope preloaded with 7.5mm/7.0mm ET tubes for males and females respectively. ET tube position will be confirmed by auscultation and capnography. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA Grade - I , II
Age group 18-60 years of either sex
All patients scheduled to undergo elective surgery in the supine position under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Thrombocytopenia or coagulopathy
Nasal polyp, nasal obstruction and h/o previous nasal surgeries
Non-cooperative patients
Pregnant females
Patients allergic to study drug |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the ease and success rate of fibreoptic
intubation after nebulisation using lignocaine with
dexmedetomidine, lignocaine alone and
dexmedetomidine alone. |
Study starts 30 minutes prior to fibreoptic intubation till 15 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the hemodynamic parameters in three groups. |
The hemodynamic parameters recorded are heart rate, O2 saturation, systolic & diastolic blood pressure. These parameters will be recorded at baseline, after nebulization for 20 minutes & at 1 minute, 3 minutes, 5 minutes & 15 minutes post intubation. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/08/2025 |
| 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="4"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drharesh1996@gmail.com].
- For how long will this data be available start date provided 18-07-2025 and end date provided 18-07-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After obtaining approval from Ethic Committee of our Institute, this observational study will be performed on 60 ASA I-II adult patients of either gender, aged 18-60, scheduled for elective surgeries under general anaesthesia will be chosen after obtaining their consent to participate in this study. Standard anaesthesia monitoring will be established (ECG, NIBP, CAPNOGRAPHY, HR, SPO2), IV access with 18G IV canula will be secured. The patients will be divided into three groups as per the discretion of the anaesthesiologist and patient’s clinical condition as Group D, Group L, Group DL to receive nebulization with 4% lignocaine 5ml, dexmedetomidine 2mcg/kg, 4% lignocaine 5ml + dexmedetomidine 2mcg/kg respectively. Glycopyrrolate 0.2mg IM will be given 30 minutes before surgery and two drops of 0.1% Xylometazoline will be instilled in both the nostrils. Patients will be nebulized for 20 minutes before intubation along with oxygenation with nasal prongs at a flowrate of 4L/min. Adequate local anaesthesia will be confirmed by heaviness of the tongue and dryness of posterior pharynx of patients. During fibreoptic intubation, 2ml lignocaine 4% will be administered by spray-as-you-go technique. Fibreoptic intubation will be performed by using flexible fibreoptic bronchoscope preloaded with 7.5mm/7.0mm ET tubes for males and females respectively. ET tube position will be confirmed by auscultation and capnography. Grading system will be used for assessing intubating conditions, vocal cord positions, cough severity, comfort during intubation and post intubation assessment. Intubation time is defined as the time from passing the fibreoptic endoscope tip through the nostril to the first reading obtained by capnography after endotracheal intubation. Continuous monitoring of vitals will be done at baseline, after nebulization and post intubation at 1, 3, 5, 15 minutes. Sedation level will be assessed after nebulisation just before procedure with Ramsay Sedation score. Patients will be induced with standard GA protocol. |