| CTRI Number |
CTRI/2014/02/004397 [Registered on: 11/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of fentanyl(opoid analgesic) and dexmedetomidine (sedative -analgesic)on pain and discomfort associated with central venous catheter insertion |
|
Scientific Title of Study
|
Effects of fentanyl and dexmedetomidine on pain and discomfort associated with central venous catheter insertion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aloka Samantaray |
| Designation |
Additional Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care
Sri Venkateswara Institute of Medical Sciences
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aloka Samantaray |
| Designation |
Additional Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care
Sri Venkateswara Institute of Medical Sciences
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aloka Samantaray |
| Designation |
Additional Professor |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care
Sri Venkateswara Institute of Medical Sciences
Sri Venkateswara Institute of Medical Sciences
Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences
|
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Sri Venkateswara Institute of Medical Sciences
Tirupati: 517507.
Andhra Pradesh. INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anesthesiology and critical Care |
Sri Venkateswara Institute of Medical Sciences
Tirupati: 517507.
Andhra Pradesh. INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aloka Samantaray |
Intensive care units and Recovery room of Sri Venkateswara Institute of Medical Sciences |
Sri Venkateswara Institute of Medical Sciences
Tirupati: 517507.
Andhra Pradesh. INDIA
Chittoor
ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee affiliated to Sri Venkateswara institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients requiring central venous access with planned placement in the internal jugular vein as a part of normal care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% normal saline |
0.9% normal saline (10mL) used as a placebo control and infused over 10 minutes before infiltration local anaesthetics(5mL of 2% Lignocaine)for insertion of central venous catheter |
| Intervention |
Central venous catheterization |
patients requiring central venous access with planned placement in the internal jugular vein as a part of normal care |
| Comparator Agent |
Dexmedetomidine |
intravenous Sedative analgesics used at a dose of 1mcg/Kg over a period of 10 minutes before infiltrating local anesthetics (5mL of 2% Lignocaine)for insertion of central venous catheter |
| Comparator Agent |
fentanyl |
intravenous Opoid analgesicused at a dose of 1mcg/Kg over a period of 10 minutes before infiltrating local anesthetics (5mL of 2% Lignocaine)for insertion of central venous catheter |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
patients requiring central venous access with planned placement in the internal jugular vein (IJV) as a part of normal care were consented and enrolled in the study. No systemic analgesics had been administered for at least 4 hours before the procedure.
Patients were included in the study if they were awake, alert, and oriented and their medical condition was stable enough to allow them to understand and use visual analogue scale(VAS)and were 18 to 65year old. |
|
| ExclusionCriteria |
| Details |
Patients were excluded from the study if they were receiving neuromuscular blocking medications or had a disease or injury that impaired sensory transmission proximal to the procedure site. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Discomfort was assessed using an 11-point verbal numeric rating discomfort scale (VNRDS) from 0 to 10 (0: none, 10: extreme discomfort); pain was assessed by a verbal numeric rating pain scale (VNRPS) from 0 to 10 (0: no pain, 10: the worst pain imaginable) . |
five time points: time 1, at base line (T1); time 2, after initial local anesthetic injection (LAI)(T2); time 3,immediately after the procedure, the patient was asked to report the peak pain experienced during the procedure (T3);time 4, 10 minutes after completion of the procedure (T10) and time 5,60 minutes after completion of the procedure (T60) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation was assessed on a 6-point modified Observer’s assessment of alertness/sedation(OAA/S) scale .
Respiratory depression,Pruritus,Nausea and vomitting |
five time points: time 1, at base line (T1); time 2, after initial local anesthetic injection (LAI)(T2); time 3,immediately after the procedure, the patient was asked to report the peak pain experienced during the procedure (T3);time 4, 10 minutes after completion of the procedure (T10) and time 5,60 minutes after completion of the procedure (T60) |
|
|
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)
|
30/01/2014 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this randomised prospective double-blind clinical trial is to evaluate objectively whether a single dose of fentanyl (1µg.kg-1)or dexmedetomidine (1µg.kg-1) with placebo control(0.9% NS) before the procedure is more efficient for prevention pain and discomfort during central venous catheterisation.
|