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CTRI Number  CTRI/2023/09/057766 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 17/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the painkiller(analgesia) efficacy of fentanyl with ketamine and lidocaine in patients undergoing lower abdominal surgeries. 
Scientific Title of Study   Comparative evaluation of intraoperative analgesia with opioid(fentanyl) vs opioid free anaesthesia(ketamine and lidocaine) in patients undergoing lower abdominal surgeries. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAnkur Nanda 
Designation  Junior resident 
Affiliation  sharda university 
Address  School of medical sciences and research,greater noida.

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  08586939631  
Fax    
Email  ankurnanda85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR U C VERMA 
Designation  Head of department(Anaesthesia) 
Affiliation  sharda university 
Address  school of medical sciences and research,greater noida.

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  Uttam.verma@sharda.ac.in  
 
Details of Contact Person
Public Query  
Name  DR U C VERMA 
Designation  Head of department 
Affiliation  sharda university 
Address  school of medical sciences and research,greater noida.

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  Uttam.verma@sharda.ac.in  
 
Source of Monetary or Material Support  
sharda hospita,plot no 32,34,knowledge park 3,greater noida(UP) 
 
Primary Sponsor  
Name  Sharda hospital 
Address  school of medical sciences and research,sharda hospital greater noida. 
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 Uttam chandra verma  School of Medical Science And Research And Sharda Hospital, Greater Noida  Department of anaesthesia,second floor,B block.
Gautam Buddha Nagar
UTTAR PRADESH 		 9968604211

Uttam.verma@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,sharda university  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  Comparative evaluation of opioid versus opioid free anaesthesia i.e ketamine and lidocaine on intraoperative heart rate,systolic blood pressure and MAC(minimum alveolar concentration)in patient undergoing lower abdominal surgeries.  Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on intraoperative heart rate,systolic blood pressure,MAC,in patient undergoing lower abdominal surgeries. 
Comparator Agent  Comparison of fentanyl with combination Of ketamine and lidocaine  Two groups will be made,Group-F patients will receive fentanyl 2mcg/kg IV bolus at the time of induction and normal saline infusion prepration till the end of surgery.Group KL patient will receive inj ketamine 0.3mg/kg iv bolus at the time of induction and inj lidocaine 1.5mg/kg followed by 2mg/kg/hr iv infusion of lidocaine till the end of surgery,patient will be supervised intraoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient scheduled for lower abdominal surgery
Age 18-60
ASA grade 1 and 2 
 
ExclusionCriteria 
Details  BMI>30
patient having history of drug allergy to ketamine and lidocaine
pregnant female
history of psychiatric illness
history of cns,cardiovascular and renal disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparative evaluation of intraoperative analgesia with opioid(fentanyl) vs opioid free anaesthesia(ketamine & lidocaine) in patients undergoing lower abdominal surgeries.  52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate & compare the intraoperative analgesia with opioid vs opioid free anaesthesia with regard to.
bispectral index
systolic diastolic & mean blood pressure
incidence of lacrimation & sweating 		 52 weeks 
 
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   Phase 4 
Date of First Enrollment (India)   30/09/2023 
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="2"
Months="0"
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   comparative evaluation of intraoperative analgesia with opioid(fentanyl)  versus opioid free anaesthesia(ketamine and lidocaine) in patients undergoing lower abdominal surgery.
intraoperative pain will be assessed by physiological parameters(HR,BIS,Systolic,diastolic & mean blood pressure) and behavioural parameters (lacrimation and sweating)
 
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