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
|
|
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
|
|
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 |