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Trial registered on ANZCTR


Registration number
ACTRN12610000610033
Ethics application status
Approved
Date submitted
22/07/2010
Date registered
28/07/2010
Date last updated
20/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Combined Ephedrine and Lidocaine Pretreatment on pain and hemodynamic changes due to propofol injection
Scientific title
The effect of combined Ephedrine and Lidocaine pretreatment on pain due to propofol injection in patients undergoing elective surgery under general anaesthesia
Secondary ID [1] 252293 0
NIL
Universal Trial Number (UTN)
U1111-1116-1865
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain due to propofol injection 257798 0
hemodynamic changes due to propofol injection 257799 0
Condition category
Condition code
Anaesthesiology 257980 257980 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomly allocated to one of 5

groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol
2 mg/kg into a dorsal hand vein was injected.
Intervention code [1] 256860 0
Prevention
Comparator / control treatment
control intervention(s) or comparator(s)(single 2ml dose of saline via intravenous injection.
Control group
Placebo

Outcomes
Primary outcome [1] 258836 0
pain during propofol injection is assessd by face pain scale(FPS) and verbal rating scale(VRS)
Timepoint [1] 258836 0
during the injection period before loss of consciousness
Secondary outcome [1] 264948 0
mean arterial blood pressure is assessed by nonivasive automatic blood pressure measurement
Timepoint [1] 264948 0
before induction, just before intubation, and one minute after intubation
Secondary outcome [2] 264949 0
heart rate is assessed by echocardiogram monitoring
Timepoint [2] 264949 0
before induction, just before intubation, and one minute after intubation

Eligibility
Key inclusion criteria
patients with American Society of Anesthesiologists(ASA) physical status I and

II, undergoing elective surgery performed under general anesthesia
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with

difficulty in communication, those with a history of adverse response to propofol, lidocaine, or

ephedrine, and those with allergic, neurologic or cardiovascular disease and patients, who had

received an analgesic medication within 24 hr before surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by two of the anesthesiologists during preoperative rounding,.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (2ml’s) Each syringe will be labeled A ,B,C,D orE according to its contents.
. The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the induction of anesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment outside Australia
Country [1] 2776 0
Iran, Islamic Republic Of
State/province [1] 2776 0
qazvin

Funding & Sponsors
Funding source category [1] 257324 0
Self funded/Unfunded
Name [1] 257324 0
marzieh khezri
Country [1] 257324 0
Iran, Islamic Republic Of
Funding source category [2] 257325 0
University
Name [2] 257325 0
Qazvin university of medical science
Country [2] 257325 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin university of medical science
Address
shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256565 0
Hospital
Name [1] 256565 0
rajaei hospital
Address [1] 256565 0
padegan street,qazvin,Iran
postal code:3413996134
Country [1] 256565 0
Iran, Islamic Republic Of
Other collaborator category [1] 251394 0
Hospital
Name [1] 251394 0
kosar hospital
Address [1] 251394 0
,taleghani street,qazvin,Iran
postal code:34188 99581
Country [1] 251394 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259350 0
Qazvin Medical University Science
Ethics committee address [1] 259350 0
shahid bahonar,Ave3419759811 Qazvin ,Iran
postal code:34197/59811
Ethics committee country [1] 259350 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259350 0
Approval date [1] 259350 0
Ethics approval number [1] 259350 0
278

Summary
Brief summary
Objectives: Injection pain and hypotension are two main adverse effects of propofol which

distresses patient. The aim of this prospective double blind study was to compare the effect

of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and

hemodynamic changes due to propofol induction.

Methods: 165adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5

groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30), ephedrine 70microgram/kg(E70), lidocaine0.5mg/kg -ephedrine30 microgram/kg(LE) or 2ml saline (S) intravenously.After one minute propofol
2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial

blood pressure and heart rate were recorded before induction, just before intubation, and one

minute after intubation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31425 0
Address 31425 0
Country 31425 0
Phone 31425 0
Fax 31425 0
Email 31425 0
Contact person for public queries
Name 14672 0
Marzieh Beigom Khezri
Address 14672 0
Marzieh Beigom Khezri, , Department of Anesthesiology , Qazvin University of Medical Science Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 14672 0
Iran, Islamic Republic Of
Phone 14672 0
+98-912-3811009
Fax 14672 0
+98-281-2236378
Email 14672 0
[email protected]
Contact person for scientific queries
Name 5600 0
Marzieh Beigom Khezri
Address 5600 0
Marzieh Beigom Khezri, , Department of Anesthesiology , Qazvin University of Medical Science, Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 5600 0
Iran, Islamic Republic Of
Phone 5600 0
+98-912-3811009
Fax 5600 0
+98-281-2236378
Email 5600 0
[email protected]

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Results publications and other study-related documents

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