| CTRI Number |
CTRI/2025/04/085320 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of inhaling lignocaine to IV administration of lignocaine to decrease blood pressure spikes during throat tube insertion, finding both effective with IV being slightly better. |
|
Scientific Title of Study
|
Evaluation of lignocaine nebulization with intravenous lignocaine in attenuation of pressor response to laryngoscopy and 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 |
Dr Anjali soni |
| Designation |
Junior Resident Gandhi Medical College |
| Affiliation |
Gandhi medical college and Associated Hamidia hospitals Bhopal M.P |
| Address |
2nd floor Block 1 Operation Theatre Department of Anaesthesiology Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9783700497 |
| Fax |
|
| Email |
anjalisoni62499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Awasya |
| Designation |
Professor |
| Affiliation |
Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P |
| Address |
2nd floor Block 1 Operation Theatre Department of Anaesthesiology Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8435725830 |
| Fax |
|
| Email |
awasya.84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajni Thakur |
| Designation |
Associate Professor (Designated) |
| Affiliation |
Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P |
| Address |
2nd floor Block 1 Operation Theatre Department of Anaesthesiology Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9200062118 |
| Fax |
|
| Email |
dr.rajni_1507@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical college and Associated Hamidia Hospitals Bhopal M.P India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College and Associated hospitals |
| Address |
Sultania road royal market bhopal M.P |
| 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 Sonal Awasya |
Hamidia Hospital |
OT complex Second Floor Department of Anaesthesiology Gandhi Medical College Sultania road royal market Bhopal M.P India 462001
Bhopal
MADHYA PRADESH |
9200314936
awasya.84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gandhi Medical College Bhopal |
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 |
| Comparator Agent |
Intravenous 2% lignocaine |
A detailed pre-anaesthetic checkup will be done. Baseline
investigations will be carried out. A written informed and
valid consent will be taken after explaining the anaesthetic
procedure in detail.
Patient will be taken to the preoperative room 30 minutes
before surgery and preoperative basal heart rate,blood
pressure and spo2 will be recorded.
The patient will receive intravenous 2% lignocaine 2 mg/kg undiluted using a simple face mask
with Compressor Nebulizer 10 min before induction. Patient
will be taken inside Operation Theatre and standard monitors
such as Electrocardiogram (ECG), pulse oximeter (SpO2 )
and Non-invasive sphygmomanometer (NIBP) cuff will be
attached.
All patients will be pre-oxygenated with 100% oxygen for 3
minutes by a face mask and pre-medicated with inj.
Glycopyrrolate0.2mg i.v. ,inj. ondansetron 4 mg i.v., Inj.
Midazolam 1mg&Inj. Fentanyl 2 µg/kg iv.
90 sec before induction.
Induction will be done with inj.propofol( 2-3)mg/kg iv ,after
loss of consciousness and confirmation of adequacy of mask
ventilation endotracheal intubation was facilitated with inj.
Scholine 2 mg/kg iv. Laryngoscopy will be performed using
Macintosh laryngoscope, under visualization of vocal cords a
lubricated (2% lignocaine jelly) cuffed endotracheal tube of
appropriate size was passed. After confirming bilaterally
equal air entry, the endotracheal tube will be secured.
Anaesthesia will be maintained with 60% Nitrous Oxide and
40% Oxygen , 1%isoflurane/sevoflurane and inj.
Atracurium0.1 mg/kg i.v. SOS. EtCO2 monitoring will be
done throughout the procedure. |
| Intervention |
Lignocaine 2% nebulisation |
A detailed pre-anaesthetic checkup will be done. Baseline
investigations will be carried out. A written informed and
valid consent will be taken after explaining the anaesthetic
procedure in detail.
Patient will be taken to the preoperative room 30 minutes
before surgery and preoperative basal heart rate,blood
pressure and spo2 will be recorded.
The patient will receive Lignocaine (2%)
nebulization 2 mg/kg undiluted using a simple face mask
with Compressor Nebulizer 10 min before induction. Patient
will be taken inside Operation Theatre and standard monitors
such as Electrocardiogram (ECG), pulse oximeter (SpO2 )
and Non-invasive sphygmomanometer (NIBP) cuff will be
attached.
All patients will be pre-oxygenated with 100% oxygen for 3
minutes by a face mask and pre-medicated with inj.
Glycopyrrolate0.2mg i.v. ,inj. ondansetron 4 mg i.v., Inj.
Midazolam 1mg&Inj. Fentanyl 2 µg/kg iv.
90 sec before induction.
Induction will be done with inj.propofol( 2-3)mg/kg iv ,after
loss of consciousness and confirmation of adequacy of mask
ventilation endotracheal intubation was facilitated with inj.
Scholine 2 mg/kg iv. Laryngoscopy will be performed using
Macintosh laryngoscope, under visualization of vocal cords a
lubricated (2% lignocaine jelly) cuffed endotracheal tube of
appropriate size was passed. After confirming bilaterally
equal air entry, the endotracheal tube will be secured.
Anaesthesia will be maintained with 60% Nitrous Oxide and
40% Oxygen , 1%isoflurane/sevoflurane and inj.
Atracurium0.1 mg/kg i.v. SOS. EtCO2 monitoring will be
done throughout the procedure.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent
Patients undergoing elective surgery requiring general anaesthesia
Patients of either sex
ASA Grade I & II
Patients having MPG I &II
Not allergic to study drug |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with anticipated difficult intubation
Patients with HTN COPD IHD and arrhythmia
History of allergy or contraindication to to study drugs
Pre existing hypotension (systolic blood pressure less than 90 mmHg)
Pre existing bradycardia (heart rate less than 60 beats per minute)
Current use of medications affecting blood pressure or heart rate ( beta-blockers calcium channel blockers)
History of gastroesophageal reflux disease (GERD) or significant oral or pharyngeal pathology
ASA grade III IV V
Pregnancy or breastfeeding Psychiatric patients
Patients with hepatic and renal dysfunction
More than 1 attempt of intubation or more than 30 seconds intubation time |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean heart rate
Mean systolic blood pressure
Mean Diastolic blood pressure
MAP (mean arterial pressure) |
Baseline vitals
T1-one minute post intubation & laryngoscopy
T3-Three minute post intubation & laryngoscopy
T5-Five minute post intubation & laryngoscopy
T7-Seven minute post intubation & laryngoscopy
T10-Ten minute post intubation & laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases with side effects |
10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anjalisoni62499@gmail.com].
- For how long will this data be available start date provided 02-05-2025 and end date provided 02-05-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The major responsibility of an anaesthesiologist is to secure airway to provide adequate ventilation to the patient during general anaesthesia. Endotracheal intubation is the gold standard of securing the airway. Laryngoscopy and endotracheal intubation is associated with intense sympatho-adrenal stimulation resulting in increase in heart rate (HR) and blood pressure (BP) consequent to the release of catecholamines . The cardiovascular response is a reflex phenomenon. Intravenous lignocaine has been used to suppress cough during tracheal intubation,laryngospasm and cough during extubation . It has also been used to suppress airway hyperactivity and mitigate bronchoconstriction . Intravenous lignocaine with its well established centrally depressant and anti-arrhythmic effects is found to be more suitable alternative to attenuate the stress response as compared to other forms of lignocaine. |