| CTRI Number |
CTRI/2023/10/059186 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effectiveness of two different doses of nebulised dexmedetomidine with lignocaine for awake fibreoptic intubation. |
|
Scientific Title of Study
|
"Comparison of effectiveness of two different doses of nebulized dexmedetomidine with lignocaine for
awake fibreoptic intubation in patients under general anaesthesia: A randomized double-blinded controlled study" |
| 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 Surendra Kumar Sethi |
| Designation |
Associate Professor |
| Affiliation |
Ravindra nath Tagore medical college udaipur Rajasthan |
| Address |
Department of Anaesthesiology
Ravindra nath Tagore medical college udaipur Rajasthan
PINCODE -313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587150598 |
| Fax |
9587150598 |
| Email |
drsurendrasethi80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kumar Sethi |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
R.N.T MEDICAL COLLEGE UDAIPUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
R.N.T MEDICAL COLLEGE UDAIPUR
PINCODE -313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587150598 |
| Fax |
9587150598 |
| Email |
drsurendrasethi80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay kumar lodhi |
| Designation |
Pg resident |
| Affiliation |
R.N.T medical college |
| Address |
Department of anaesthesiology Ravindra nath Tagore medical college udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7772832656 |
| Fax |
|
| Email |
abhaykumarlodhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, Rabindranath Tagore Medical college Udaipur Rajasthan 313001 |
|
|
Primary Sponsor
|
| Name |
Rabindranath Tagore Medical College |
| Address |
Dept of Anaesthesiology Rabindranath Tagore Medical College,
Udaipur Rajasthan 313001 |
| 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 abhay kumar lodhi |
Maharana Bhupal Government Hospital Udaipur Rajasthan 313001 |
MAIN SURGERY OT 2 nd floor ,ENT OT,NEURO SURGERY OT 5th floor SSB BUILING,UROLOGY OT 5th floor SSB BUILDING,R.N.T MEDICAL COLLEGE UDAIPUR RAJSTHAN.
Udaipur
RAJASTHAN |
7772832656
abhaykumarlodhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE CONTROLLER ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H720||Central perforation of tympanic membrane, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (5) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (6) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (7) ICD-10 Condition: H701||Chronic mastoiditis, (8) ICD-10 Condition: H712||Cholesteatoma of mastoid, (9) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lignocaine 4% 4 ml with dexmedetomidine 2 microgram/kg |
In third group we will nebulised patients with ignocaine 4% 4 ml with dexmedetomidine 2 microgram/kg [total 5 ml] before awake fibre optic intubation for 15 minutes. |
| Comparator Agent |
lignocaine 4% 5ml |
Nebulisation with 4%lignocaine 5 ml just before awake fibre optic intubation for 15 minutes. |
| Comparator Agent |
lignocaine 4% with dexmedetomidine [5ml] |
In 2 nd group we will nebulised patients with lignocaine 4% 4ml with dexmedetomidine 1 microgram/kg[total 5 ml] before awake fibre optic intubation for 15 minutes. |
| Intervention |
AWAKE FIBER OPTIC INTUBATION |
Comparison of effectiveness of two different doses of nebulised dexmedetomidine with lignocaine for awake fibreoptic intubation in patients undergoing surgery under general anaesthesia.In first group we will give lignocaine plan & and in 2 nd & 3rd group we will give 1&2 microgram dexmedetomidine with 4% lignocaine respectively in each group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
2.Patients with American Society of Anesthesiologists (ASA) Physical Status (PS) I and II
3.Patients with Mallampati Class I and II |
|
| ExclusionCriteria |
| Details |
1. Patients who have not given consent.
2.Patients with age <18 and >50 years
3. Patients with ASA PS III and IV and Mallampati class III and IV
4. Patients with BMI >35 kg/m2 |
|
|
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 |
| Cough severity score during awake fiber optic intubation |
During awake fiber optic intubation (2 minutes) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubation comfort score
Post intubation behavior score/Assessment
Post operative patient satisfaction score
Ramsay sedation score
Haemodynamics
Side effects like nausea/vomiting ,bradycardia,hypotension,respiratory depression ,oxygen desaturation etc. |
Upto 24 hr post operatively |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
06/11/2023 |
| 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="1"
Days="15" |
|
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
|
Among the various methods to facilitate AFOI, topical anaesthesia with LA (lignocaine) nebulisation is a commonly used technique. However, topical anaesthesia with lignocaine alone may be inadequate in some patients. Dexmedetomidine, a selective alpha- 2 adrenergic agonist, that provides both analgesia and sedation without causing respiratory depression. Only two studies have been done where this combination (dexmedetomidine in a dose of 0.6 µg/kg and 1 µg/kg) has been used for flexible fiberoptic bronchoscopy Till date.We hypothesised that combination of nebulised dexmedetomidine-lidocaine could reduce the incidence of moderate to severe coughing during AFOI With more intubation comfort, better post-intubation tolerance and patient satisfaction along with adequate sedation and stable haemodynamics.The present study has been planned with an aim of comparing the effectiveness of two different doses of nebulised dexmedetomidine with lignocaine for AFOI in patients undergoing surgery under general anaesthesia.
|