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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.


 
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