| CTRI Number |
CTRI/2025/07/090927 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| 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
|
Attenuation of hemodynamic stress responses during extubation with intravenous diltiazem versus intravenous lignocaine in patient undergoing elective laparoscopic surgeries |
|
Scientific Title of Study
|
Attenuation of hemodynamic stress responses during extubation with intravenous diltiazem versus intravenous lignocaine in patient undergoing elective laparoscopic surgeries - a prospective randomised control 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 |
SALMANISHA S A |
| Designation |
POST GRADUATE |
| Affiliation |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE , VIDYANAGAR HUBBALLI
Dharwad KARNATAKA 580021 India |
| Phone |
9880849587 |
| Fax |
|
| Email |
salmahameedsullia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SWARNAMBA U N |
| Designation |
PROFESSOR |
| Affiliation |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE , VIDYANAGAR HUBBALLI
Dharwad KARNATAKA 580021 India |
| Phone |
9448559776 |
| Fax |
|
| Email |
saakshiswarna79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SWARNAMBA U N |
| Designation |
PROFESSOR |
| Affiliation |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE , VIDYANAGAR HUBBALLI
Dharwad KARNATAKA 580021 India |
| Phone |
9448559776 |
| Fax |
|
| Email |
saakshiswarna79@gmail.com |
|
|
Source of Monetary or Material Support
|
| KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE, HUBBALLI 580021 INDIA |
|
|
Primary Sponsor
|
| Name |
SALMANISHA S A |
| Address |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE VIDYANAGAR HUBBALLI 580021 INDIA |
| Type of Sponsor |
Other [SELF] |
|
|
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 SALMANISHA S A |
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF ANAESTHESIOLOGY
KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE , VIDYANAGAR HUBBALLI 580021 INDIA Dharwad KARNATAKA |
09880849587
salmahameedsullia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KARNATAKA INSTITUTE OF MEDICAL SCIENCES HUBBALLI ETHICS COMMITTEE |
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 |
INTRAVENOUS DILTIAZEM |
ATTENUATION OF HEMODYNAMIC STRESS RESPONSES DURING EXTUBATION |
| Comparator Agent |
INTRAVENOUS LIGNOCAINE |
ATTENUATION OF HEMODYNAMIC STRESS RESPONSES DURING EXTUBATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
weight 40 to 80kg
height 150 to 170cm
american society of anaesthesiologists physical status 1 and 2
patients with informed valid written consent |
|
| ExclusionCriteria |
|
|
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 assess and compare the attenuation of hemodynamic stress responses with intravenous diltiazem versus intravenous lignocaine during extubation in patient undergoing elective laparascopic surgeries |
To look for attenuation of extubation resposes from the time of test drug administration to till 5 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse events , if any |
|
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Endotracheal
extubation is the translaryngeal removal of a tube from the trachea via the
nose or mouth. Endotracheal extubation almost always associated with
haemodynamic changes due to reflex sympathetic discharge caused by
epipharyngeal and laryngopharyngeal stimulation. This increase in
sympathoadrenal activity may result in hypertension tachycardia and
arrhythmias. In addition, many other stimuli affect these hemodynamic changes
including pain from wound and emergence from anaesthesia.These
hemodynamic changes during extubation and emergence from anesthesia may cause
dangerous increases in myocardial oxygen demand in patients with coronary
artery disease CAD and in those with risk factors for CAD.Laparoscopic procedures are also associated with several
undesirable cardiorespiratory perturbances. A combination of several factors,
namely pneumoperitoneum, patient position, anaesthesia and hypercapnia from the
absorbed CO2 are responsible for the haemodynamic changes observed during
laparoscopy. These includes increased HR increased arterial pressures,
increased systemic vascular resistance and increased pulmonary vascular
resistance. Hemodynamic changes induced by the pneumoperitoneum and more particularly the increased systemic vascular resistance outlast the
release of the pneumoperitoneum. Thus, at the end of the procedure, even when
intra-peritoneal pressure has returned to normal the heart rate and arterial
pressure remain elevated. These changes may add on to the changes provoked by
extubation.Many pharmacological methods have been devised to reduce the
extent of hemodynamic events, including esmolol, alfentanil, fentanyl,
diltiazem, high dose of opioids, local anaesthetics like lignocaine and
vasodilating drugs like nitroglycerine. Lignocaine, a sodium channel blocker, attenuates the
hemodynamic response to tracheal extubation by inhibiting sodium channels in
the neuronal cell membrane, decreasing the sensitivity of the heart muscles to
electric impulses. Diltiazem, a calcium channel blocker, attenuates hemodynamic
response by blocking voltage sensitive L type channels and inhibiting calcium
entry mediated action potential in smooth and cardiac muscle. So, the present study was undertaken to study and compare the
effect of intravenous diltiazem and intravenous lignocaine on attenuation of
hemodynamic responses to endotracheal extubation in patients undergoing
laparoscopic surgeries.
|