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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]

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

Condition category

Condition code

Anaesthesiology

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]

Prevention

Comparator / control treatment

oral starch tablets 30 minutes before induction

Control group

Placebo

Outcomes

Primary outcome [1]

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]

While rocuronium was being injected, withdrawal movement was graded by an investigator.

Secondary outcome [1]

nil

Timepoint [1]

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?

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]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Gozde Bumin Aydin

Address [1]

Ahmet Taner Kislali mah. Orun Villalari 2764. sok no:7 Cayyolu

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

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

Dr Gozde Bumin Aydin

Address

Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90-532-6453235

Fax

[email protected]

Contact person for public queries

Name

Gozde Bumin Aydin

Address

Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90 5326453235

Fax

[email protected]

Contact person for scientific queries

Name

Gozde Bumin Aydin

Address

Ahmet Taner Kislali mah. Orun villalari 2764. sok no:7 Cayyolu
Diskapi Yildirim Beyazit Education and Reasearch Hospital

Country

Turkey

Phone

+90 5326453235

Fax

[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

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Documents added automatically

No additional documents have been identified.

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