Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000435886
Ethics application status
Approved
Date submitted
12/04/2012
Date registered
18/04/2012
Date last updated
19/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Local Warming versus Local Cooling on Injection Pain After Propofol Administration During Anaesthesia Induction
Scientific title
Effect of Local Warming versus Local Cooling on Injection Pain After Propofol Administration During Anaesthesia Induction in those Scheduled for Elective Surgery
Secondary ID [1] 280304 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
propofol injection pain 286262 0
Condition category
Condition code
Anaesthesiology 286483 286483 0 0
Pain management
Anaesthesiology 286484 286484 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After obtaining local research ethical committee approval and patients’ informed written consent, 120 patients were studied between age groups of 18 and 65 years old, of ASA groups I and III, and who were scheduled for elective surgery under general anesthesia . The exclusion criteria were; being pregnant and breastfeeding women, having a medical history of epilepsy, having cardiac conduction failure,having lipid metabolism disorder, receiving antiarrhytmic or analgesic drugs, having liver or kidney failure, being allergic to propofol and difficulty for iv cannulation.
Without any premedication, the patients were given, 5 ml/kg/hour crystalloid solution, through a 20 G iv cannule which is attached on the dorsum of the hand. Patients in the operation room were monitored for; standard electrocardiography (ECG), blood pressure non invasively and peripheral oxygen saturation (Drager;Infinity delta MS13466E539D,USA). The patients were randomly allocated, using sealed envelopes, to one of following 3 groups of 40 each:
1. Local warming group , (Group I): Before anesthesia induction patients were subjected to 40 degrees C hot application for 2 minutes with a bair hugger device (a device blowing hot air through a blanket to be worn over the body), through the vein trace which the cannula were attached.
2. Local cooling group (Group II): Before anesthesia induction patients were subjected to +2-4 degrees C cooling application for 2 minutes with cold water bags kept in refrigerator, through the infusion vein trace.
3. No intervention group (Group III): Patients in this group were accepted as control group and were not subjected to any procedure.
Propofol prepared in room temperature (10 mg/ml ampoule, Fresenius) were administered as 2,5 mg/kg dose and within one minute to all groups. On the 15th second with the start of injection, the patients were asked about suffering any pain. Findings observed until the injection finished and the response was recorded according to the 5-point Verbal Rating Scale (VRS) (0= no pain, 1= mild pain, 2= moderate pain, 3= severe pain, 4= severe pain accompanied by facial grimacing and arm withdrawal).. After propofol injection, opioid and muscle relaxant (only for patients who will be intubated) were given Then the operation progressed with an intubation or a laryngeal mask. Hemodynamics were measured and recorded at control (T0), 1.(T1), 2.(T2), 3.(T3) minutes.
Intervention code [1] 284669 0
Treatment: Drugs
Intervention code [2] 284707 0
Treatment: Devices
Comparator / control treatment
In Group III (Control); no intervention was applied.
Control group
Active

Outcomes
Primary outcome [1] 286937 0
To investigate the effect of local warming and cooling on pain induced by propofol.Findings observed until the injection finished and the response was recorded according to the 5-point Verbal Rating Scale (VRS) (0= no pain, 1= mild pain, 2= moderate pain, 3= severe pain, 4= severe pain accompanied by facial grimacing and arm withdrawal).
Timepoint [1] 286937 0
Patients were asked about any discomfort at the 15th seconds of injection
Secondary outcome [1] 297032 0
Change in hemodynamics; patients in the operation room were monitored for; standard electrocardiography (ECG), blood pressure non invasively for measurement of the hemodynamic variables
Timepoint [1] 297032 0
Hemodynamic variables were measured and recorded at control (T0), 1.(T1), 2.(T2), 3.(T3) minutes

Eligibility
Key inclusion criteria
ASA groups I and III, and who were scheduled for elective surgery under general anesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Being pregnant and breastfeeding women, having a medical history of epilepsy, having cardiac conduction failure,having lipid metabolism disorder, receiving antiarrhytmic or analgesic drugs, having liver or kidney failure, being allergic to propofol and difficulty for iv cannulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After obtaining written informed consent , the patients were randomly assigned to one of the three groups as the responsible anesthesiologist opened the next envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 4249 0
Turkey
State/province [1] 4249 0

Funding & Sponsors
Funding source category [1] 285082 0
Self funded/Unfunded
Name [1] 285082 0
Country [1] 285082 0
Primary sponsor type
Individual
Name
Serdar Koseoglu
Address
Ministry of Health, Ankara Training and Research Hospital, Department of Anaesthesiology and Intensive Care, Ulucanlar Cad. 06340, Ankara, Turkey
Country
Turkey
Secondary sponsor category [1] 283948 0
None
Name [1] 283948 0
Address [1] 283948 0
Country [1] 283948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287097 0
Ministry of Health, Ankara Training and Research Hospital Ethics Committee
Ethics committee address [1] 287097 0
Ethics committee country [1] 287097 0
Turkey
Date submitted for ethics approval [1] 287097 0
Approval date [1] 287097 0
17/08/2011
Ethics approval number [1] 287097 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34047 0
Address 34047 0
Country 34047 0
Phone 34047 0
Fax 34047 0
Email 34047 0
Contact person for public queries
Name 17294 0
Hale Yarkan Uysal
Address 17294 0
Ministry of Health, Ankara Training and Research Hospital, Department of Anaesthesiology and Intensive Care, Ulucanlar Cad. 06340, Ankara, Turkey
Country 17294 0
Turkey
Phone 17294 0
+903125953175
Fax 17294 0
+903123633396
Email 17294 0
[email protected]
Contact person for scientific queries
Name 8222 0
Hale Yarkan Uysal
Address 8222 0
Ministry of Health, Ankara Training and Research Hospital, Department of Anaesthesiology and Intensive Care, Ulucanlar Cad. 06340, Ankara, Turkey
Country 8222 0
Turkey
Phone 8222 0
+903125953175
Fax 8222 0
+903123633396
Email 8222 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.