Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000432718
Ethics application status
Approved
Date submitted
11/04/2013
Date registered
16/04/2013
Date last updated
16/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of dexketoprofen trometamol on rocuronium injection pain with general anesthesia
Scientific title
The effect of dexketoprofen trometamol on rocuronium injection pain in patients undergoing elective surgery with general anesthesia
Secondary ID [1] 282311 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
we are studying rocuronium injection pain 288853 0
Condition category
Condition code
Anaesthesiology 289195 289195 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexketoprofen Trometamol (arvelles as the commercial name)is the S(+) enantiomer of ketoprofen, which is a COX-1 and COX-2 inhibitor arylpropyonic acid. It is a newly developed, centrally acting NSAID with potency similar to that of mu-opioid agonists. In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability profile after oral administration. Therefore arvelles might be suitable for preventing this distressing side-effect. However, no report has examined as to whether arvelles pretreatment reduces the withdrawal movement caused by rocuronium injection.
The aim of this study was to compare the efficacy of pretreatment with oral arvelles with plasebo tablets, without tourniquet, for the prevention of withdrawal response from rocuronium injection. We will administer an oral capsule of 25 mg single dose 30 minutes before induction
Intervention code [1] 286923 0
Prevention
Comparator / control treatment
oral starch tablets 30 minutes before induction
Control group
Placebo

Outcomes
Primary outcome [1] 289305 0
The aim of this study was to compare the efficacy of pretreatment with oral arvelles with plasebo tablets, without tourniquet, for the prevention of withdrawal response from rocuronium injection.While rocuronium was being injected, withdrawal movement was graded by an investigator, who was blinded to patient group assigned as follows: grade 0 = no response, grade 1 = movement/withdrawal at the wrist only, grade 2 = movement/withdrawal involving the arm only (elbow/shoulder), and grade 3 =generalized response with movement/withdrawal in more than one extremity, cough, or breath-holding
Timepoint [1] 289305 0
While rocuronium was being injected, withdrawal movement was graded by an investigator.
Secondary outcome [1] 302194 0
nil
Timepoint [1] 302194 0
nil

Eligibility
Key inclusion criteria
After Institutional Ethic Comitee approval and written, informed consent, will enroll 150 patients into the study, aged 18 to 75 years, belonging to American Society of Anesthesiologists physical status classification I and III patients will be scheculed for elective surgery with general anesthesia.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with difficult venous access on the dorsum of the hand, NSAID allergy, existence of serious hepatic, renal and gastric disease, history of peptic ulcer disease and coagulopathy, use of corticosteroids within the last 7 days; and use of anticoagulants within the last month, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, will be excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
3/01/2013
Date of last participant enrolment
Anticipated
1/03/2013
Actual
6/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 5009 0
Turkey
State/province [1] 5009 0

Funding & Sponsors
Funding source category [1] 287072 0
Self funded/Unfunded
Name [1] 287072 0
Gozde Bumin Aydin
Country [1] 287072 0
Turkey
Primary sponsor type
Individual
Name
Gozde Bumin Aydin
Address
Ahmet Taner Kislali mah. Orun Villalari 2764. sok no:7 Cayyolu
Country
Turkey
Secondary sponsor category [1] 285847 0
None
Name [1] 285847 0
Address [1] 285847 0
Country [1] 285847 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Rocuronium is a commonly used steroidal non-depolarizing neuromuscular blocking agent with a rapid onset of action and an intermediate duration. However, even in unconscious patients during anesthetic induction, rocuronium causes withdrawal movement of the injected hand or arm, or generalized movements of the body after intravenous injection even leading to reflux of gastric contents and pulmonary aspiration. Pain from the injection of rocuronium is experienced by 75-100% of patients and 84% during induction of anesthesia after loss of consciousness. Although no patient complained of pain or recall after recovery, this withdrawal movement was most likely due to pain at the site of injection.
Dexketoprofen is the S(+) enantiomer of ketoprofen, which is a COX-1 and COX-2 inhibitor arylpropyonic acid. It is a newly developed, centrally acting NSAID with potency similar to that of mu-opioid agonists. In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability profile after oral administration. Therefore arvelles might be suitable for preventing this distressing side-effect. However, no report has examined as to whether arvelles pretreatment reduces the withdrawal movement caused by rocuronium injection.
The aim of this study was to compare the efficacy of pretreatment with oral arvelles with plasebo tablets, without tourniquet, for the prevention of withdrawal response from rocuronium injection.
After Institutional Ethic Comitee approval and written, informed consent, will enroll 150 patients into the study, aged 18 to 75 years, belonging to American Society of Anesthesiologists physical status classification I and III patients will be scheculed for elective surgery with general anesthesia. Patients with difficult venous access on the dorsum of the hand, NSAID allergy, existence of serious hepatic, renal and gastric disease, history of peptic ulcer disease and coagulopathy, use of corticosteroids within the last 7 days; and use of anticoagulants within the last month, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, will be excluded from the study.
Using a computer-generated randomized table in a sealed envelope, patients will randomly assigned to recieve either placebo tablets or arvelles 25 mg 30 minutes before induction.
After 3 min of preoxygenation, 2.5% thiopental sodium 5 mg/kg will be injected. When the verbal response and the eyelash reflex were abolished, an intubating dose of rocuronium 0.6 mg/kg is injected over 5 seconds and intravenous fluid is continously be administer for 10 seconds. While rocuronium is being injected, withdrawal movement will be graded by an investigator, who is blinded to patient group assigned as follows: grade 0 = no response, grade 1 = movement/withdrawal at the wrist only, grade 2 = movement/withdrawal involving the arm only (elbow/shoulder), and grade 3 =generalized response with movement/withdrawal in more than one extremity, cough, or breath-holding .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39190 0
Dr Gozde Bumin Aydin
Address 39190 0
Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39190 0
Turkey
Phone 39190 0
+90-532-6453235
Fax 39190 0
Email 39190 0
[email protected]
Contact person for public queries
Name 39191 0
Dr Gozde Bumin Aydin
Address 39191 0
Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39191 0
Turkey
Phone 39191 0
+90 5326453235
Fax 39191 0
Email 39191 0
[email protected]
Contact person for scientific queries
Name 39192 0
Dr Gozde Bumin Aydin
Address 39192 0
Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital
Country 39192 0
Turkey
Phone 39192 0
+90 5326453235
Fax 39192 0
Email 39192 0
[email protected]

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No Supporting Document Provided



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