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CTRI Number  CTRI/2024/05/066957 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the effect of two drugs, paracetamol and dexmedetomidine, on perioperative vitals & postoperative pain in patients undergoing laparoscopic cholecystectomy under general anaesthesia 
Scientific Title of Study   Comparative evaluation of paracetamol and dexmedetomidine on peri-operative haemodynamics and post-operative analgesia in patients undergoing laparoscopic cholecystectomy under general 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 Nandita Kad 
Designation  Professor 
Affiliation  Pt B.D. Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and critical care, Pt.B.D. Sharma, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9896335544  
Fax    
Email  kadnandita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navdeep Singh 
Designation  Junior resident 
Affiliation  Pt B.D. Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and critical care, Pt. B.D. Sharma, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9465473731  
Fax    
Email  navdeep1804@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navdeep Singh 
Designation  Junior resident 
Affiliation  Pt B.D. Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology AND Critical care, Pt. B.D. Sharma, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9465473731  
Fax    
Email  navdeep1804@gmail.com  
 
Source of Monetary or Material Support  
Pt. B.D Sharma PGIMS Rohtak Haryana, pin: 124001 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and critical care, Pt. B D Sharma, PGIMS, Rohtak, Haryana, 124001, INDIA  
Type of Sponsor  Other [Government medical college] 
 
Details of Secondary Sponsor  
Name  Address 
NONE   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navdeep Singh  Pt. B.D Sharma PGIMS Rohtak  Modular OT complex, 3rd floor, PGIMS Rohtak, Haryana, pin: 124001
Rohtak
HARYANA 
9465473731

navdeep1804@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt B.D Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  To compare the role of intravenous paracetamol and dexmedetomidine on peri-operative hemodynamics and post-operative analgesia in patients undergoing laparoscopic cholecystectomy  first of all, baseline SPO2, NIBP, and pulse rate will be recorded before during, and after drug administration . pain score will be estimated at 1/2, 2, 4, and 6 hours postoperatively 
Intervention  to study effect on peri-operative hemodynamics and post-operative analgesia in patients undergoing laparoscopic cholecystectomy  Intravenous paracetamol or intravenous dexmedetomidine will be administered to patients undergoing laparoscopic cholecystectomy. Effects on vitals and post-operative pain will be noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The study will include 90 patients of either sex.
age 18–60 years, belonging to American Society of
Anesthesiologists (ASA) physical status of I-II with
scheduled for elective laparoscopic cholecystectomy
under general anaesthesia and will be assigned to
two groups 
 
ExclusionCriteria 
Details  Obesity
Already receiving beta blocker or alpha-2 agonists
History of allergy to test drug
History of hypertension with or without medication
History of cardiopulmonary disease
History of hepatic and renal dysfunction
History of psychological disorders
History of alcohol and drug abuse
Receiving opioid analgesics during last 24 hours
before surgery
Heart Rate less than 50bpm
Refusal to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To study the effectiveness of paracetamol & dexmedetomidine on peri-operative
hemodynamics and postoperative analgesia in patients undergoing laparoscopic
cholecystectomy under general anaesthesia . 
First of all, spo2, NIBP, and pulse rate will be recorded at baseline before and after the administration of drugs and pain score will be assessed at 1/2, 2, 4, and 6 hours in patients undergoing laparoscopic cholecystectomy under general anaesthesia . 
 
Secondary Outcome  
Outcome  TimePoints 
All the vital parameters (spo2, pulse rate, NIBP, & pain score) will be assessed.  At baseline, just before & after the administration of drugs & pain score at 1/2, 2, 4 & 6 hours post-operatively 
 
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)   17/05/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Laparoscopic cholecystectomy is gold standard surgical treatment for cholelithiasis
and cholecystitis. It is a minimally invasive procedure in which inert gas is insufflated into
the abdomen, creating pneumoperitoneum. Due to the combined effect of anaesthetic agents,
positioning of patient, absorption of gas and pneumoperitoneum, there is occurrence of
marked hemodynamic changes. Peri-operative hemodynamics monitoring plays a critical
role for improving post-operative outcomes. In an anaesthetized patient, it provides crucial
information regarding cardiac output, volume status, tissue perfusion, and depth of anaesthesia
and adequate pain control. After CO2 insufflation, if the intraabdominal pressure is more than 10
mmHg, then there is significant alteration of haemodynamics due to vena cava compression
and pooling of blood in lower extremities, causing decrease in venous return and cardiac
output. The increase in peripheral vascular resistance is contributed by increase in intra
thoracic pressure due to increased intra-abdominal pressure and also by the release of
catecholamines and vasopressin due to mechanical stimulation of peritoneal receptors.
Sudden stretching of peritoneum during laparoscopy may lead to arrhythmias (bradycardia).
and asystole).
Post-operative pain management and monitoring of pain relief have become important
post-operative quality measure. The desired goal is to alleviate or eliminate pain and its
discomfort in patients with the fewest side effects.3 Adequate pain relief is crucial to treating
patients undergoing surgery. There have been studies suggesting that, out of the total number of
patients undergoing surgery, more than 80% experience acute post operative pain and out of
these, approximately 75%, report severity of post operative pain as moderate , severe or
extreme. There are also evidences to suggest that less than 50% of patients reports adequate
pain relief after surgery.4 For the management of post operative pain, various
pharmacological agents have been tried (opioid vs non-opioid) via different routes ( oral,
intravenous, neuraxial, and regional).
Dexmedetomidine is a highly selective alpha-2 receptor agonist. It is having
sympatholytic, sedative, analgesic, and opioid-sparing properties and does not cause respiratory
depression. It also decreases the incidence of postoperative nausea and vomiting. Intravenous
dexmedetomidine also has efficacy in improving perioperative hemodynamic stability and
post-operative analgesia. In addition, it also decreases the intraoperative consumption of
anaesthetics and opioids, It also has direct antiemetic effect by activating alpha-2
receptors. Minor side effects like hypotension and bradycardia can occur with
dexmedetomidine .
          Paracetamol is widely used as an antipyretic and analgesic and its presumed mechanism  of
action being inhibition of central cycloxygenase (COX 3), which causes decreased production
of prostaglandins in the CNS. It might also act through opioidergic system and NMDA receptors
and by regulation of inhibitory serotonergic pathways.
 Since perioperative hemodynamics and post operative pain are the major
concerns in patients undergoing laparoscopic cholecystectomy under general anaesthesia, we
decided  to perform a study to compare the effect of Paracetamol and
dexmedetomidine on perioperative hemodynamics and postoperative analgesia.
 
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