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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Aloka Samantaray  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 Contact Person Scientific Query	Name  Aloka Samantaray  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 Contact Person Public Query	Name  Aloka Samantaray  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 Modification(s)	No of Sites = 1   Contact Person  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   9493547653 aloksvims@gmail.com
Details of Ethics Committee Modification(s)	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	Status  Not Applicable
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 Modification(s)	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 Modification(s)	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 Modification(s)	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"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	30/01/2014
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details	nill
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.