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CTRI Number  CTRI/2023/11/060025 [Registered on: 20/11/2023] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study on evaluation of a tool named perfusion index to assess effectiveness of pain medication dexmedetomidine in reducing pain during laparoscopic gall bladder removal surgery under general anaesthesia 
Scientific Title of Study   Study on evaluation of perfusion index as a tool to assess the analgesic efficacy of dexmedetomidine during 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 Sarath BabuPD 
Designation  Post graduate  
Affiliation  Amala Institute of Medical Sciences  
Address  Department of Anaesthesiology Amala Institute of Medical sciences Amala Nagar Thrissur Kerala

Thrissur
KERALA
680555
India 
Phone  8547327875  
Fax    
Email  sarathbabupd93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Derlin Thomas 
Designation  Assistant professor  
Affiliation  Amala Institute of Medical Sciences  
Address  Department of Anaesthesiology Amala Institute of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9447768944  
Fax    
Email  derlin.t@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Derlin Thomas 
Designation  Assistant professor  
Affiliation  Amala Institute of Medical Sciences  
Address  Department of Anaesthesiology Amala Institute of Medical Sciences Amala Nagar Thrissur

Thrissur
KERALA
680555
India 
Phone  9447768944  
Fax    
Email  derlin.t@gmail.com  
 
Source of Monetary or Material Support  
Amala Institute of Medical Sciences Anaesthesia department Chavara building First floor PAC room 
 
Primary Sponsor  
Name  Amala Institute of Medical Sciences  
Address  Amala Institute of Medical Sciences, Amala Nagar, Thrissur,Kerala , India 680555 
Type of Sponsor  Private medical college 
 
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 Sarath BabuPD  Amala Institute of Medical Sciences   Amala Institute of Medical Science Amala Nagar Thrissur - 680555
Thrissur
KERALA 
8547327875

sarathbabupd93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amala Institute of Medical Science   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  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Physical state ASA 1-2
Age group 18 years to 70 years
Patients undergoing elective laparoscopic cholecystectomy surgeries under General anaesthesia  
 
ExclusionCriteria 
Details  Patients not willing to participate in this study
History of allergy to the drugs in the study
Patients with neurological or psychiatric illness,chronic pain disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome - incidence and severity of intra-op pain stimulus assessed using perfusion index tool  Before induction,after induction,after intubation,1,2,3,2,4,6,8,10,15,20,25,30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of perfusion index with hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure   Before induction, after induction, after intubation,1,2,3,2,4,6,8,10,15,20,25,30 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   26/11/2023 
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="1"
Months="6"
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
Modification(s)  
Quantifying nociception under anaesthesia is difficult and therefore reaction to nociception is used for monitoring through increased sympathetic activity or the corresponding decreased sympathetic stimulation
In any way surgical procedures as far as an anaesthetist is concerned in providing pain free journey is most important. So to identify nociceptive condition as fast as possible via an effective simple reliable tool is important. The usual parameters we use for pain assessment is heart rate, blood pressure variation and in this study we are assessing whether perfusion index can assess the nociceptive changes in surgery in an effective and reliable way.
In this study we mainly aim at comparing the parameters used for assessing pain like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure along with variations of perfusion index in patients receiving dexmedetomidine infusion intra operatively and patients receiving conventional anaesthesia for laparoscopic cholecystectomy procedures.
After meeting inclusion and exclusion criteria a total number of 60 patients will be recruited for this longitudinal study in a consecutive sampling manner.
Primary objective of study is to compare the variation in perfusion index in response to pain stimulus and variability of perfusion index in subsequent pain stimulus after intravenous administration of dexmedetomidine during laparoscopic cholecystectomy surgeries under General anaesthesia and to compare the perfusion index with hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure with or without dexmedetomidine 
 
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