| CTRI Number |
CTRI/2022/05/042595 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
16/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of local numbing drug (lidocaine) when given directly into blood or as a throat spray to decrease the response to passing an artificial breathing tube through the throat in patients with elevated BP posted for surgery |
|
Scientific Title of Study
|
Comparison of Intravenous and Atomized Topical
Lidocaine in Attenuating the Hemodynamic
Responses to Tracheal Intubation in
Surgical Patients with pre existing hypertension:Randomized Controlled Trial. |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavya Shivanagouda Patil |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesia and critical care, second floor, Institute block, JIPMER.
JIPMER campus road, Gorimedu, Priyadarshini Nagar, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9845887900 |
| Fax |
|
| Email |
kavya.s.patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesia and Critical care, second floor, Institute block, Jipmer
JIPMER campus road, Gorimedu, Priyadarshini Nagar, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anesthesia and Critical care, second floor, Institute block, Jipmer
JIPMER campus road, Gorimedu, Priyadarshini Nagar, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post graduate Education and Research |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Kavya Patil |
Jipmer hospital |
Department of anesthesia and critical care, second floor, institute block, Jipmer, Jipmer campus road, Gorimedu, Puducherry
Pondicherry
PONDICHERRY |
9845887900
kavya.s.patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous lidocaine |
Injection lidocaine 1.5 mg/kg injection intravenously over a period of 30 seconds |
| Intervention |
Topical lidocaine |
Injection Lignocaine 1.5 mg/kg applied topically using atomiser over a period of 30 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients between 18 – 80 years belonging
to American Society of Anesthesiologists grade II
with controlled hypertension ( Preoperative blood
pressure less than 140/90 mm of Hg, controlled
using single or combination of antihypertensive
drugs)undergoing oro-tracheal intubation. posted
for elective non cardiac surgery lasting more than
one hour. |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway
2. Patients who are allergic to lignocaine
3. Patients with history of ischemic heart
disease and any vascular aneurysm
4. Pregnant women
5. Patients with active Gastroesophageal
reflux disease GERD
6. Patients with oropharyngeal pathology |
|
|
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 difference between the
preinduction and one minute post intubation
systolic arterial pressure, between the atomized
topical lidocaine group and intravenous lidocaine
group following laryngoscopy and tracheal
intubation.
|
pre intubation and one minute post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean arterial pressure
2.Diastolic pressure
3.Heart rate
4.Rate Pressure Product
5.ECG changes
6.Arrhythmias
|
One minute intervals upto 10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
22/05/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and tracheal intubation following induction of anesthesia have been reported to cause significant increases in blood pressure and pulse rate. These changes are usually of short duration and pose little threat to healthy patients. But in patients with hypertension, short periods of hypertension or tachycardia may increase the risk of cardiac ischemia and other vascular events. Various pharmacological drugs have been tested in an attempt to prevent or attenuate these hemodynamic responses. Deep general anesthesia, intravenous administration of adrenergic blocking drugs like esmolol , or vasodilating drugs like diltiazem and nitroglycerin are often tried to prevent or attenuate the hemodynamic response to laryngoscopy and intubation. Though they are proven to reduce the intubation response, their undesirable side effects like hypotension, bradycardia, bronchospasm, and conduction
blocks warrant close monitoring and may
necessitate monitoring of intra-arterial pressure.
Lidocaine is the most commonly studied drug in
this regard either through intravenous route or as
laryngo-tracheal topical anesthetic drug prior to
intubation. Lidocaine is also a common drug
available in the operation rooms and the effect of
lidocaine to attenuate the hemodynamic response
to tracheal intubation is well proven by many
studies but the majority of them are limited to
intravenous route of administration in low-risk
surgical patients. Topical lidocaine has also been
shown to attenuate the hemodynamic response to
intubation. Theoretically topical lidocaine due to
regional action may suppress the cardiovascular
reflex response to laryngoscopy and intubation as
compared to intravenous administration. Also,
the systemic toxicity of lidocaine may be
avoided. Studies directly comparing intravenous
and topical lidocaine in attenuating intubation
response are very limited to low risk surgical
population and lack adequate power to conclude
the superiority of each other. Hence our study has
been undertaken to make this direct comparison
between topical and intravenous lidocaine in
addition to fentanyl in attenuating the intubation
hemodynamic response. Patients with controlled hypertension whose blood pressure is maintained
below 140/90 millimeter of mercury with a single or combination of oral
medications belonging to American Society of Anesthesiologists ASA II
posted for noncardiac elective surgery are selected as the study population.
They will receive premedication on the night prior to the surgery and at least
90 minutes before the surgery which includes Diazepam 100 mcg/kg with an
upper limit of 10mg and aspiration prophylaxis drugs like Metoclopramide
10 mg and Famotidine 10 mg. The patients will be brought into the operating
room, allowed to relax for a few minutes till they feel calm and composed,
following which monitors are attached and continuous monitoring of noninvasive blood pressure, pulse rate, oxygen saturation and ECG (leads I, II,
III and V5) will be started. An intravenous access will be secured under 1ml
of 2% lidocaine skin infiltration and injection Fentanyl 2 mcg/kg will be
slowly injected subsequently. Simultaneously, preoxygenation with 100%
oxygen will be started using a circle breathing system. Five minutes after
injection of Fentanyl, baseline recordings of systolic, mean, diastolic blood
pressure, pulse rate, and ST segment measurement from leads II and V5 will
be noted and Rate pressure product will be calculated. Sealed opaque
envelopes will be opened at this time. One syringe labeled as topical drug
and another one labeled as the intravenous drug depending on the group
allocation will be prepared by the independent anesthesiologist not involved
in the study. Then they will be induced with intravenous 10% Propofol at a dose of 2 mg/kg until the loss of verbal response of the patient. Then
vecuronium 0.1 mg/kg will be administered. The LMA Madgic intubation
atomizer (Teleflex) device will be inserted into the oral cavity of patients in
the topical lidocaine(TL) group and mask ventilation will be started with
sevoflurane in oxygen air mixture. After insertion of the LMA Magic device
another reading of blood pressure (systolic, mean and diastolic)and heart rate
will be noted. To facilitate atomization of topical drug, Oxygen at the flow
rate of 2 L/ min will be administered through one of the ports of the device
from a separate oxygen flow meter. The patients in the Topical Lidocaine
(TL) group will receive 1.5 mg/Kg of 2% lidocaine through the atomizer
over period of 30 seconds. The Intravenous Lidocaine (IL) group will receive
1.5 mg/Kg of 2% lidocaine intravenously. The drug will be injected over a
period of 30 seconds. Mask ventilation will be continued so that
laryngoscopy and intubation are performed three minutes after the delivery
of lidocaine. During mask ventilation the end tidal carbon-di-oxide will be
kept between the range of 35 to 45 mmHg. The intubation will be performed
by an experienced anesthesiologist (Third year Junior Resident / Senior
Resident / Consultant) to avoid prolonged intubation or multiple attempts at
intubation. Laryngoscopy is done with a standard McIntosh blade and
tracheal intubation is done with an appropriate size tracheal tube under direct
vision. Following intubation, blood pressure, pulse rate, ECG and EtCo2, are
noted every one minute for the first 10 minutes by the investigator blinded to
the group allocation. |