| CTRI Number |
CTRI/2025/08/092488 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effects on heart rate and blood pressure when using two different medicines 4 percentage lignocaine and 1 microgram per kg dexmedetomidine given as a mist through a mask before inserting a breathing tube
|
|
Scientific Title of Study
|
Comparison of hemodynamic changes after nebulization with 4 percentage lignocaine and with 1 microgram per kg dexmedetomidine for endotracheal 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 |
chandan nag |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College and Hospital,Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7000749962 |
| Fax |
|
| Email |
nagchandan112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Kapoor |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital,Chandigarh |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121549 |
| Fax |
|
| Email |
kapoor.dheeraj72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India |
| 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 Chandan Nag |
Government Medical College And Hospital, Chandigarh |
Department of Anaesthesia and Intensive care,Block D,Level 5,GMCH,Sector 32B,Chandigarh,160030,India
Chandigarh
CHANDIGARH |
7000749962
nagchandan112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,GMCH Chandigarh |
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 |
nebulization with 4% lignocaine and with 1 mcg/ kg dexmedetomidine prior to endotracheal intubation |
Nebulization will be started 30 minutes before induction of anaesthesia, nebulization of lignocaine or dexmedetomidine will be prepared and administered by an independent investigator in the preoperative area. Nebulization will be carried out with a nebulizer face mask with oxygen at 8 L/min creating a fine mist till the entire volume will be dispersed, and this usually will take 15–20 minutes. It will be stopped when there will be no further mist. However, the investigator will be authorized to intervene if the patients will develop bradycardia, will experience increased sedation or decrease in peripheral oxygen saturation. In such an event, the nebulization will be stopped, and the patient treated will be accordingly
5 ml 4% Lignocaine nebulization to Group II (control
group) will be administered using a nebulizer face mask with a continuous flow of 100%
oxygen at 8 L/min for 15-20 min before induction of anaesthesia in supine position with head
propped up (30-45) degree according to the group assigned. |
| Comparator Agent |
nebulization with 4% lignocaine and with 1 mcg/ kg dexmedetomidine prior to endotracheal intubation |
Nebulization will be started 30 minutes before induction of anaesthesia, nebulization of lignocaine or dexmedetomidine will be prepared and administered by an independent investigator in the preoperative area. Nebulization will be carried out with a nebulizer face mask with oxygen at 8 L/min creating a fine mist till the entire volume will be dispersed, and this usually will take 15–20 minutes. It will be stopped when there will be no further mist. However, the investigator will be authorized to intervene if the patients will develop bradycardia, will experience increased sedation or decrease in peripheral oxygen saturation. In such an event, the nebulization will be stopped, and the patient treated will be accordingly. Dexmedetomidine 50 mcg (mixed with 0.9% normal saline to a total volume of 5 ml) nebulization to Group I (study group)will be administered using a nebulizer face mask with a continuous flow of 100% oxygen at 8 L/min for 15-20 min before induction of anaesthesia in supine position with head propped up (30-45) degree according to the group assigned. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) Status I and II
Patients undergoing elective surgery requiring general anaesthesia with endotracheal
intubation |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effect of nebulization of 4%
Lignocaine and nebulization of 1 mcg/kg dexmedetomidine on heart rate and blood
pressure after endotracheal intubation with
C Mac D blade videolaryngoscopy
|
baseline, after
nebulization, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) and 2 hr postsurgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect of nebulization of 4%
Lignocaine and nebulization of 1 mcg/kg
dexmedetomidine on postoperative sore
throat after endotracheal intubation with C
Mac D blade videolaryngoscopy |
Postoperatively, an independent observer blinded to the allocation group will assess the patient
for postoperative pain and sore throat at 2-hr post-surgery, when patients will be recovered
from the effects of anaesthetic agents |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
19/08/2025 |
| 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="6"
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
|
My thesis investigates the comparative effects of nebulized 4 % lignocaine versus 1mcg/kg Dexmedetomidine on hemodynamic changes during endotracheal intubation using C-MAC D blade videolaryngoscopy in patients under general anaesthesia. The study aims to assess heart rate, blood pressure variations and incidence of postoperative sore throat. A total of 104 ASA I-II adult patients scheduled for elective surgeries will be enrolled and randomly assigned to two groups receiving either lignocaine or dexmedetomidine nebulization 30 minutes before induction. The prospective, randomized, controlled study includes standardized anaesthesia protocols and independent monitoring. Outcomes will be statistically analyzed for significance in hemodynamic stability and postoperative discomfort. The research adheres to ethical guidelines and has institutional clearance. This study aims to identify a safer, more effective pre-intubation nebulizing agent potentially improving patient safety and comfort during anaesthesia by mitigating pressor responses commonly triggered by laryngoscopy and intubation.
Aim To compare the hemodynamic changes after nebulization with 4%lignocaine and 1mcg/kg Dexmedetomidine for endotracheal intubation in general anaesthesia.
Primary objective To observe the effect of nebulization of 4%Lignocaine and nebulization of 1mcg/kg dexmedetomidine on heart rate and blood pressure after endotracheal intubation with C Mac D blade videolaryngoscopy
Secondary Objective To observe the effect of nebulization of 4%Lignocaine and nebulization of 1mcg/kg Dexmedetomidine on postoperative sore throat after endotracheal intubation with C Mac D blade videolaryngoscopy.
Methodology All eligible patients according to inclusion and exclusion criteria will be provided nebulization of the drug according to group allocated. The group allocation will be done using computer-generated randomization table depending on the nebulized drug used and closed sealed envelope technique will be used as blinding method. Nebulisation will be started 30 minutes before induction of anaesthesia., nebulization of lignocaine or dexmedetomidine will be prepared and administered by an independent investigator in the preoperative area. Nebulization will be carried out with a nebulizer face mask with oxygen at 8L /min creating a fine mist till the entire volume will be dispersed, and this usually will take 15-20 minutes. It will be stopped when there will be no further mist. Dexmetomidine 50mcg (mixed with 0.9%normal saline to a total volume of 5ml ) nebulization to Group I (study group) and 5 ml 4%Lignocaine nebulization to Group II (control group) will be administered using a nebulizer face mask with a continuous flow of 100% oxygen at 8L/min for 15-20 minutes before induction of anaesthesia in supine position with head propped up (30-45) degree according to the group assigned.
Outcomes measured 1.The patients will be left undisturbed for a period of 10 minutes after intubation and the vital parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulseoximetry spo2 and EtCO2 will be recorded at baseline, after nebulization, after induction, post-intubation, 1, 5 and 10 minutes and 2 hours post surgery 2. Postoperative will assess the patient for postoperative pain and sore throat at 2-hr post-surgery. |