| CTRI Number |
CTRI/2023/12/060488 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
02/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of esmolol and lidocaine on middle cerebral artery during emergence from anaesthesia |
|
Scientific Title of Study
|
A comparative analysis of the effect of single dose esmolol and lidocaine on Middle cerebral artery velocity(MCA) during emergence from anaesthesia |
| 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 Lhingneilam Haokip |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE , AMU |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal Nehru Medical college , Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8787312917 |
| Fax |
|
| Email |
lhingneilamhaokip61@gmail.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Obaid Ahmed Siddiqui |
| Designation |
Associate Professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE , AMU |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal Nehru Medical college , Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897695761 |
| Fax |
|
| Email |
obaidahmad2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LHINGNEILAM HAOKIP |
| Designation |
Junior RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE , AMU |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal Nehru Medical college , Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8787312917 |
| Fax |
|
| Email |
lhingneilamhaokip61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical college, Aligarh muslim university, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical college AMU Aligarh |
| Address |
Department of Anesthesiology and critical care, JNMCH, AMU |
| 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 Lhingneilam Haokip |
Jawaharlal Nehru Medical College, AMU, Aligarh |
Department of Anaesthesiology and critical care, Jawaharlal Nehru Medical College, AMU, Aligarh
Aligarh
UTTAR PRADESH |
8787312917
lhingneilamhaokip61@gmail.co.in |
|
|
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: K807||Calculus of gallbladder and bile duct without cholecystitis, (2) ICD-10 Condition: H701||Chronic mastoiditis, (3) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (4) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparision of drugs effect on middle cerebral artery velocity and hemodynamic parameters during emergence from surgery |
Measuring MCA velociy with the help of Transcranial doppler(TCD) two minutes after administration of drugs |
| Comparator Agent |
Esmolol, Lidocaine |
1)ESMOLOL Group: inj. Esmolol 1.5mg/kg Intravenously 2)LIDOCAINE Group: inj. Lidocaine 1.5mg/kg Intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Physical status of ASA I & II
2) Mallampati score class I & II |
|
| ExclusionCriteria |
| Details |
1) Physical status of ASA III & IV
2) Those with significant systemic disorder
3) Those with uncontrolled hypertension and cerebrovascular disease
4) Those with co-morbid disease
5) Allergy to local anaesthetic and those on beta- blocker therapy
Pregnant female
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of esmolol and lidocaine on Middle cerebral artery velocity during emergence from anaesthesia |
1) T0- During anaesthesia
2) T1- before administration of drugs (when train of four response is more than 90%)
3) T2- After two minute of administration of drug
4) T3- After three minutes of extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To analyse and compare the effect of esmolol and lidocaine on hemodynamic parameters e.g systolic blood pressure(SBP), heart rate(HR) during emergence from anaesthesia
2. To correlate the change in hemodynamic parameters (SBP, HR) with MCA velocity during emergence from anaesthesia
3. Any adverse effect e.g hypotension, bradycardia, cough, bronchospasm, laryngospasm |
1) T0- During anaesthesia
2) T1- before administration of drugs (when train of four response is more than 90%)
3) T2- After two minute of administration of drug
4) T3- After three minutes of extubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/12/2023 |
| 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="2"
Months="0"
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
|
Tracheal intubation and extubation are critical steps during anaesthetic care where cardiovascular and respiratory decompensation can occur such as tachycardia, hypertension, arrythmias, myocardial ischaemia, bradycardia or laryngospasm. These potentially fatal complications related to extubation result from stimulation of the larynx, trachea and bronchi which increase the release of catecholamine concentration. Cerebral hyperaemia occur during extubation which is demonstrated by concomitant increase in cerebral blood flow velocity(CBFV). A possible mechanism of hyperaemia and increasd CBFV is the sympathetic stimulation associated with emergence. Pharmacological strategies such as local anaesthesia, N-Methyl - D -aspartate(NMDA) antagonist , alpha -2- agonist and beta- blocker can significantly blunt the sympathetic overactivity and reduce the rate of serious outcome relate to emergence.
We hypothesize that blunting the sympathetic overactivity will decrease CBFV and cerebral hyperaemia at emergence from anaesthesia Therefore, we planned this prospective, randomised, double blind, placebo controlled study to comparatively analyse the effect of single dose esmolol and lidocaine on MCA velocity during emergence from anaesthesia.
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