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CTRI Number  CTRI/2012/01/002391 [Registered on: 31/01/2012] Trial Registered Prospectively
Last Modified On: 01/10/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Strategic preoperative fentanyl administration before general anaesthesia for holistic perioperative analgesia 
Scientific Title of Study   Critical Evaluation Of Pre-Induction Fentanyl As ‘Perioperative’ Analgesic’ In Patients Undergoing Laparoscopic Surgery:An Evolving Concept Or Imminent Need?  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amitabh Dutta 
Designation  Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar
Central
DELHI
110060
India 
Phone  01142252513  
Fax  01125861002  
Email  duttaamitabh@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amitabh Dutta 
Designation  Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar

DELHI
110060
India 
Phone  01142252513  
Fax  01125861002  
Email  duttaamitabh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital  
Address  Sir Ganga Ram Hospital Old Rajinder Nagar
Sir Ganga Ram hospital Old Rajinder Nagar
Central
DELHI
110060
India 
Phone  01142252513  
Fax  01125861002  
Email  nitinsethi77@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi  
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain and Perioperative Medicine  
Address  Sir Ganga Ram Hospital, Old Rajinder Nagar 110060 ,New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Amitabh Dutta  Department of Anesthesiology , Pain and Perioperative Medicine Sir Ganga Ram Hospital  Old Rajinder Nagar New Delhi 110060 DELHI
New Delhi
DELHI 
01142252513
01125861002
duttaamitabh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sir Ganga Ram Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  perioperative pain during laparoscopic surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group I will recieve single intravenous bolus dose  Group I will recieve single intravenous bolus dose of fentanyl 3mcg/kg  
Intervention  Group II will recieve 3 divided intermittent intravenous boluses(0,3,6 minutes)  Group II will 3 divided intermittent intravenous boluses(0,3,6 minutes)of fentanyl 1mcg/kg per bolus(total dose 3mcg/kg) 
Intervention  Group III will recieve continuous intravenous infusion over 6 minutes  Group III will receive continuous intravenous infusion of fentanyl 3mcg/kg over 6 minutes 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Male or female gender
2.Aged 20-70 years
3.Scheduled surgery: Laparoscopic surgery (30-minutes to 150- minutes)
4.General anaesthesia
5.Elective nature of intervention
6.Consenting for surgery
 
 
ExclusionCriteria 
Details  1. Patients with uncompensated systemic co-morbidity [cardiac (hypertension, coronary artery disease, cardiomyopathy, arrhythmias), respiratory (bronchial asthma, COPD), endocrinology (diabetes mellitus, thyroid disease), hepato-renal, CNS
2. Allergy to opioid drugs
3. History of substance abuse
4. Psychiatric illness
5. Any previous history of respiratory depression with opioids 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.The impact of three equi-dose pre-induction IV fentanyl dosing strategy on indices related to prevailing ‘balanced anaesthesia’ concept.

2.Analysis of best pre-induction fentanyl dosing strategy in terms of balanced anaesthesia, postoperative analgesia and side-effects reduction.  
From first dose of fentanyl to 48 hrs time point 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/02/2012 
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="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Opioids are routinely administered during the pre-induction period of general anaesthesia (GA) process.  Fentanyl, a synthetic opioid, is most commonly employed opioid agent owing to its analgesic potency, ease of administration and lack of significant side effects at routine intravenous doses (2-10 mg/kg).  The analgesic use of fentanyl is random and at the best scattered over the perioperative espanse of GA.  Surprisingly, the pre-emptive effect of fentanyl as a sole analgesic has not been studied.  Primarily, it is preferably, used as a reactive analgesic agent to contain subjective pain sensation the patient expresses postoperatively.  In addition, the use of fentanyl is more often than not inadequate owing to fear among anesthesia physician of its side effects including over-sedation, respiratory depression, postoperative nausea and vomiting (PONV), cough and chest wall rigidity.

 

This research aims to use fentanyl during the pre-induction period with a proactive strategy to gain pre-emptive analgesia, objective attainment of ‘balanced anesthesia’ end points, stable hemodynamics and avoidance of its common side effects.  The phased pattern of research is expected to add to the evolution of a new concept, i.e. ‘perioperative analgesia’, which will positively impact overall post surgical patient outcome.

 


 
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