| CTRI Number |
CTRI/2020/10/028483 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 group of anaesthetic drugs,propofol-ketamine and propofol- dexmedetomidine to provide general anaesthesia and observe & compare change in vitals like blood pressure , heart rate and recovery profile like emergence, orientation time in patients undergoing laparoscopic cholecystectomy |
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Scientific Title of Study
|
A COMPARATIVE EVALUATION OF PROPOFOL- KETAMINE AND PROPOFOL – DEXMEDETOMIDINE IN TERMS OF HEMODYNAMIC VARIABLES AND RECOVERY CHARACTERISTICS IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY’’
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Pankaj |
| Designation |
DNB resident |
| Affiliation |
JLN HOSPITAL AND RESEARCH CENTRE BHILAI |
| Address |
Room no 1F Sector 8 Street 50 Near JLN hospital Bhilai
JLNHRC SECTOR 9 BHILAI
Durg
CHHATTISGARH
490009
India |
| Phone |
8984796602 |
| Fax |
|
| Email |
priyapankaj1802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vineeta Dwivedi |
| Designation |
Head of the department (MD Anaesthesia) |
| Affiliation |
Jawaharlal Nehru hospital and research centre |
| Address |
Main OT complex, Jawaharlal Nehru hospital and research centre Sector 9 Bhilai Chhatisgarh
JLNHRC sector 9 bhilai
Durg
CHHATTISGARH
490009
India |
| Phone |
9407983478 |
| Fax |
|
| Email |
vineetadwivedi13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vineeta Dwivedi |
| Designation |
Head of the department (MD Anaesthesia) |
| Affiliation |
Jawaharlal Nehru hospital and research centre |
| Address |
Main OT complex, Jawaharlal Nehru hospital and research centre Sector 9 Bhilai Chhatisgarh
JLNHRC sector 9 bhilai
Durg
CHHATTISGARH
490009
India |
| Phone |
9407983478 |
| Fax |
|
| Email |
vineetadwivedi13@gmail.com |
|
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Source of Monetary or Material Support
|
| Jawaharlal Nehru hospital and research hospital Sector 9 Bhilai Chhatisgarh |
|
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Primary Sponsor
|
| Name |
Jawaharlal Nehru hospital and research centre |
| Address |
JLNHRC Sector 9 Bhilai Chhatisgarh |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priya Pankaj |
Jawaharlal Nehru hospital and research centre |
Room no 03 Department of Anaesthesiology main Operation theatre Jawaharlal Nehru hospital and research centre Sector 9 Bhilai
Durg
CHHATTISGARH |
8984796602
priyapankaj1802@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS RAIPUR |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug combination of propofol-dexmedetomidine will be used in one group of patients and hemodynamic variables and recovery characteristics will be observed in patients undergoing laparoscopic cholecystectomy |
Dexmedtomidine will be given prior to induction with propofol and intraoperative hemodynamic variables like heart rate, systolic blood pressure, diastolic blood pressure and recovery characteristics will be observed and compared |
| Comparator Agent |
Drug combination Propofol- Ketamine will be used in other group of patients and will be compared for hemodynamic variables and recovery characteristics in patients undergoing laparoscopic cholecystectomy |
ketamine will be administered before induction with Propofol to the patient and hemodynamic variables like mean arterial blood pressure, heart rate and recovery characteristics like emergence, response and post operative sedation and first analgesic requirement time is observed |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II
Both genders
Age from 18 years to 60 years
Patients undergoing laparoscopic cholecystectomy |
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| ExclusionCriteria |
| Details |
Age below 18 years and above 60 years
ASA III and ASA IV
Pregnant or breast - feeding patient
Patients with baseline heart rate less than 55/minute
Patients with hypertension, heart blocks and ischemic heart diseases
Allergic to study drugs
Laparoscopic cholecystectomy converted to open cholecystectomy
Patient with severe hepatic, renal, endocrine and cardiac dysfunction
Patient refusal to participate in the study
Patients on sedatives, psychiatric medications, opioid therapy |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Which among the two drug combination has better hemodynamic stability and recovery characteristics. Comparison in terms of Intraoperative hemodynamic variables including heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure and Recovery characteristics |
Intraoperative heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure measured every 10 mins interval . Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Hemodynamics , Recovery profile, post operative analgesic requirement, PACU stay |
Intraoperative hemodynamic variables like heart rate , mean arterial blood pressure every 10 mins interval . Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge |
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Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
17/11/2020 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This is a comparative study of two anaesthetic drug combination propofol-ketamine and propofol-dexmedetomidine in terms of hemodynamic variables like heart rate,blood pressure and recovery characteristics in two study groups of patients undergoing laparoscopic cholecystectomy under general anaesthesia. It will be conducted in department of anaesthesiology, JLNHRC and it is hospital based, time bound, prospective, comparative randomised control trial and sample size is 56 patients undergoing laparoscopic cholecystectomy. Two groups of 28 patients each will be made. After taking consent and pre anaesthetic checkup and preparation for ot, Patient will receive loading dose of either iv ketamine or iv dexmedetomidine before induction with propofol and surgery will be started. Intraoperative hemodynamic variables like heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure will be measured every 10 mins interval till the end of surgery and Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge time will be noted and compared as per the objective of the study. All data will be analysed statistically. |