CTRI

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CTRI Number

CTRI/2025/07/091286 [Registered on: 21/07/2025] Trial Registered Prospectively

Last Modified On:

18/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of nebulised dexmedetomidine and nebulised lignocaine on response to insertion of endotracheal tube for general anaesthesia

Scientific Title of Study

Effect of nebulised dexmedetomidine versus nebulised lignocaine on laryngoscopy and neuroendocrine stress response following endotracheal intubation: a randomized comparative 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 Ruchi Kapoor
Designation	Professor
Affiliation	UCMS and GTB Hospital
Address	Room no. 731 A, 7th Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi North East DELHI 110095 India
Phone	9560678023
Fax
Email	rudoc@rediffmail.com

Details of Contact Person
Scientific Query

Name	Dr Ruchi Kapoor
Designation	Professor
Affiliation	UCMS and GTB Hospital
Address	Room no. 731 A, 7th Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi North East DELHI 110095 India
Phone	9560678023
Fax
Email	rudoc@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Saumya Bhanot
Designation	Post Graduate Resident
Affiliation	UCMS and GTB Hospital
Address	2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Delhi North East DELHI 110095 India
Phone	9899719818
Fax
Email	saumya.bhanot@gmail.com

Source of Monetary or Material Support

UCMS and GTB Hospital, Delhi-110095

Primary Sponsor

Name	UCMS and GTB Hospital
Address	UCMS and GTB Hospital, Dilshad Garden, Delhi-110095
Type of Sponsor	Government 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 Ruchi Kapoor	UCMS and GTB Hospital	2nd Floor, OT Block, Department of Anaesthesiology and Critical Care, Dilshad Garden-110095 North East DELHI	9560678023 rudoc@rediffmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee- Human Research	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	Nebulised Dexmedetomidine	Each patient will receive 4mL nebulised Dexmedetomidine (1mcg/kg) over 10 minutes, 40 minutes prior to surgery.
Comparator Agent	Nebulised Lignocaine	Each patient will receive 4mL nebulised Lignocaine(4%) over 10 minutes, 40 minutes prior to surgery.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Consenting male or female patients aged 18-60 years, ASA I or ASA II scheduled for surgery under general anaesthesia.

ExclusionCriteria

Details

1. Patients with anticipated difficult airway
2. Any patient with history of ischemic heart disease, uncontrolled hypertension, cardiac blocks or any other contraindication for the use of dexmedetomidine
3. Patients sensitive to lignocaine

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
To compare the SBP immediately after intubation in Group D (Dexmedetomidine) versus Group L (Lignocaine)	Immediately after intubation

Secondary Outcome

Outcome	TimePoints
To compare between the two groups: 1. Systolic blood pressure(SBP) at 2 minutes and 5 minutes after intubation. 2. Diastolic blood pressure(DBP), mean arterial pressure(MAP) and heart rate(HR) at baseline and at intubation, 2 minutes and 5 minutes after intubation. 3. Consumption of propofol for induction of anaesthesia.	2 minutes and 5 minutes after intubation
To compare between the two group: 1. Salivary alpha amylase levels at baseline and 5 minutes post intubation 2. Serum cortisol levels at baseline and 5 minutes post intubation.	Pre- operative and 5 minutes after intubation
To compare between the two groups: 1. Sedation in post operative period 30 minutes after extubation.	Post operative

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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="3"
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 - NO

Brief Summary

Nebulised dexmedetomidine has been found to be effective in blunting the hemodynamic response that occurs following laryngoscopy at the time of intubation. Hemodynamic response can lead to an increase in heart rate, blood pressure, mean arterial pressure. It can be tolerated by young and healthy individuals but is detrimental in patients with limited cardiac reserve as it may precipitate hypertensive crisis, myocardial ischaemia, arrhythmias or increase in intra-cranial pressure in suspected individuals. Thus, it is vital to blunt these responses.

It has been observed that neuroendocrine response also occurs following laryngoscopy. However, currently there is no existing literature comparing the nebulised dexmedetomidine with nebulised lignocaine for blunting the neuroendocrine response.

Therefore, this study aims to assess the biochemical markers levels and hemodynamic profile following laryngoscopy when nebulised with dexmedetomidine versus lignocaine.

Forty ASA grade I and grade II patients presenting for general anaesthesia will be randomized into two groups, Group D and Group L based on computer generated randomized table. Allocation concealment will be done by sealed envelope technique.

Thorough pre-anaesthetic assessment will be done for all patients. After taking consent, patients will be wheeled in and standard ASA monitors will be attached in the pre-operative area and depending upon the group, the study drug will be administered through the nebuliser.

Group D will receive 4mL of Dexmedetomidine (1mcg/kg) over 10 minutes while Group L will receive 4mL of Lignocaine (4%) over 10 minutes.

Vitals will be noted at the end of 10 minutes. Any adverse event shall also be noted.

After 30 minutes, the patient will be taken up in the operating room, baseline hemodynamic parameters will be noted.

Intravenous access will be secured and 2mL sample for baseline value of cortisol will be taken. Simultaneously, 2mL of saliva sample will also be taken for measurement of salivary alpha amylase levels.

A conventional balanced general anaesthesia will be administered to all patients.

Post intubation hemodynamic parameters will be noted and same hemodynamic parameters will be noted at 2 minutes and 5 minutes (and subsequently every 5 minutes till 15 minutes and then at 30 minutes and 1 hour).

Blood samples will be taken for serum cortisol levels and saliva sample for salivary alpha amylase levels at 5 minutes post intubation.

Sedation will be assessed in post operative period using Ramsay Sedation score 30 minutes post extubation.