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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

  1. Study Design: Prospective randomised double-blind study
  2. Study population: All ASA-PS: I, II patients posted for elective surgery under general anaesthesia
  3. Study duration: 1 year
  4. Sample size: N = 65 per group 
  5. Parameters to be studied:
    1. Heart Rate (HR)
    2. Mean Arterial Pressure (MAP)
  6. Inclusion criteria:
    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
  7. Exclusion criteria:
    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
  8. Study Group: Patients will be randomly assigned by computer generated number to one of the two groups- Group A and Group B
  9. Randomisation: Randomisation will be done by Sequentially numbered, opaque, sealed envelope (SNOSE) method
  10. Blinding: A two-operator technique will be used to maintain blinding.
    1. The principal investigator will record all the hemodynamic variables
    2. 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

 
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