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
|
|
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
|
|
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.
|