| CTRI Number |
CTRI/2023/09/057535 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between nebulisation with Dexmedetomidine and Lignocaine to attenuate laryngoscopic respone |
|
Scientific Title of Study
|
A Comparative study between Nebulisation with Dexmedetomidine and Lignocaine to Attenuate Laryngoscopic Response in a tertiary care Centre In West Bengal |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrita Majumder |
| Designation |
Senior Resident |
| Affiliation |
Jagannath Gupta Institute of Medical Sciences |
| Address |
OT complex, Jagannath Gupta Institute of Medical Sciences, Buita Budge Budge, Kolkata South Twentyfour Parganas WEST BENGAL 700137 India |
| Phone |
8240277294 |
| Fax |
|
| Email |
amrita.majumder.AM@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Barnava Pal |
| Designation |
Assistant Professor |
| Affiliation |
Jagannath Gupta Institute of Medical Sciences |
| Address |
OT complex, Jagannath Gupta Institute of Medical Sciences, Buita Budge Budge, Kolkata South Twentyfour Parganas WEST BENGAL 700137 India |
| Phone |
9933552157 |
| Fax |
|
| Email |
barnavapal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Barnava Pal |
| Designation |
Assistant Professor |
| Affiliation |
Jagannath Gupta Institute of Medical Sciences |
| Address |
OT complex, Jagannath Gupta Institute of Medical Sciences, Buita Budge Budge, Kolkata South Twentyfour Parganas WEST BENGAL 700137 India |
| Phone |
9933552157 |
| Fax |
|
| Email |
barnavapal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagannath Gupta Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Jagannath Gupta Institute of Medical Sciences |
| Address |
Buita, Budge Budge, Kolkata- 700137 |
| Type of Sponsor |
Private 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 Barnava Pal |
Jagannath Gupta Institute of Medical Sciences |
OT complex, Jagannath Gupta Institute of Medical Sciences, Buita, Budge Budge, Kolkata South Twentyfour Parganas WEST BENGAL |
9933552157
barnavapal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES) |
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 |
Dexmedetomidine nebulisation |
Group A will be nebulised till the solution -Dexmedetomidine (1.5 μg/kg) diluted in sterile water to make 5 ml, finishes |
| Comparator Agent |
Lignocaine nebulisation |
Group B will be nebulised till the solution -Lignocaine (4.5 mg/kg) diluted with sterile water to make 5 ml, finishes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-60 years of either sex scheduled to undergo surgery under general anaesthesia
2. American Society of Anaesthesiologists- Physical Status-1, 2 (ASA-PS-1, 2) patient
3. Modified Mallampati grade 1 and 2
4. Patients weighing between 45 kg and 75 kg
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with bleeding disorder
3. Patients with known history of allergy, hypersensitivity
4. Unanticipated difficult intubation (Laryngoscopy time >15 seconds)
5. Patients with psychiatric disease
6. Pregnant lady |
|
|
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 |
Heart Rate (HR)
Mean Arterial Pressure (MAP) |
1. Baseline vitals will be noted (TA)
2. Vitals will be noted just after nebulisation (TB)
3. All the vital parameters will be recorded before laryngoscopy & intubation (TC)
4. All the vital parameters will be recorded immediately after laryngoscopy & intubation(T0)
5. Vital parameters will be recorded for every 2 minutes after laryngoscopy and intubation till 10 minutes (T2, T4, T6, T8, T10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
n/a |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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 |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
INTRODUCTION
Laryngoscopic response is characterised by a sudden surge in mean arterial pressure (MAP) and heart rate (HR), arising 30 seconds following direct laryngoscopy and intubation and approaches baseline in 10 minutes Various pharmacological agents are used to attenuate this noxious response with varied success.
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist having sympatholytic, sedative, hypnotic and analgesic properties. Lignocaine is an amide synthetic local anaesthetic and used commonly for decreasing airway reflexes, bronchial hyperactivity and suppress the laryngoscopic response by inhibiting sensory C fibres of the airway Administration of drugs via nebulisation route provides greater surface area for absorption and better safety profile.
AIM AND OBJECTIVE
Aim: To explore two effective nebulisation regimens to attenuate laryngoscopic response
Objective: To compare heart rate and mean arterial blood pressure after nebulisation with dexmedetomidine or lignocaine post laryngoscopy
MATERIALS AND METHODS
MATERIALS
- Study Design: Prospective randomised double-blind study
- Study population: All ASA-PS: I, II patients posted for elective surgery under general anaesthesia
- Study duration: 1 year
- Sample size: N = 65 per group
- Parameters to be studied:
- Heart Rate (HR)
- Mean Arterial Pressure (MAP)
- Inclusion criteria:
- Patients aged between 18-60 years of either sex scheduled to undergo surgery under general anaesthesia
- American Society of Anaesthesiologists- Physical Status-1, 2 (ASA-PS-1, 2) patient
- Modified Mallampati grade 1 and 2
- Patients weighing between 45 kg and 75 kg
- Exclusion criteria:
- Patient refusal
- Patients with bleeding disorder
- Patients with known history of allergy, hypersensitivity
- Unanticipated difficult intubation (Laryngoscopy time >15 seconds)
- Patients with psychiatric disease
- Pregnant lady
- Study Group: Patients will be randomly assigned by computer generated number to one of the two groups- Group A and Group B
- Randomisation: Randomisation will be done by Sequentially numbered, opaque, sealed envelope (SNOSE) method
- Blinding: A two-operator technique will be used to maintain blinding.
- The principal investigator will record all the hemodynamic variables
- An anaesthesiologist, who is not involved in the study, will administer the nebulised drugs to the patient in the absence of principal investigator
Methods
Group A will be nebulised with Dexmedetomidine (1.5 μg/kg) dissolved in sterile water to make 5 ml and similarly Group B patients will be nebulised with Lignocaine (4.5 mg/kg) diluted with sterile water 30 minutes prior to induction of anaesthesia. All the vital parameters (HR, MAP and SPO2) will be recorded immediately after laryngoscopy and intubation (T0). The patient will be left undisturbed for 10 minutes; HR, MAP and SPO2 will be recorded for every 2 minutes post laryngoscopy till 10 minutes (T2, T4, T6, T8, T10). Rescue medication used will be Inj. Propofol integrated dose if rise in MAP>20% of baseline |