Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000142437
Ethics application status
Approved
Date submitted
20/12/2015
Date registered
5/02/2016
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Hyoscine N-butylbromide for preventing propofol injection pain
Scientific title
Hyoscine N-butylbromide for preventing propofol injection pain: A randomized, placebo-controlled, double-blind study in patients undergoing routine outpatient surgery under general anesthesia
Secondary ID [1] 288192 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
propofol injection pain 297097 0
Condition category
Condition code
Anaesthesiology 297337 297337 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug administration (Hyoscine N-butylbromide) 20 mg intravenously (a single dose) just before propofol injection
Intervention code [1] 293495 0
Prevention
Intervention code [2] 293730 0
Treatment: Drugs
Comparator / control treatment
0.9 % sodium chloride (Placebo)
Control group
Placebo

Outcomes
Primary outcome [1] 296899 0
Assessment of Hyoscine N-butylbromide prevention on propofol injection pain [ Injection pain severity was assessed using the following four-point pain response scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).]
Timepoint [1] 296899 0
Ten seconds following the injection of propofol, propofol injection pain will be evaluated.
Secondary outcome [1] 320505 0
non
Timepoint [1] 320505 0
non

Eligibility
Key inclusion criteria
ASA physical status I and II, scheduled to undergo routine outpatient 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
An allergy to the study drugs, end-stage renal disease, pregnancy, patients taking sedatives or analgesics, patients requiring a rapid sequence induction and intubation, refusal to participate, and patients with a neurological or cardiovascular disease.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2016
Actual
22/02/2016
Date of last participant enrolment
Anticipated
Actual
2/01/2017
Date of last data collection
Anticipated
Actual
2/01/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7475 0
Turkey
State/province [1] 7475 0
Konya

Funding & Sponsors
Funding source category [1] 292587 0
Hospital
Name [1] 292587 0
Konya Training and Research Hospital
Country [1] 292587 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090
Country
Turkey
Secondary sponsor category [1] 291309 0
None
Name [1] 291309 0
Address [1] 291309 0
Country [1] 291309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294071 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 294071 0
Ethics committee country [1] 294071 0
Turkey
Date submitted for ethics approval [1] 294071 0
06/11/2015
Approval date [1] 294071 0
11/11/2015
Ethics approval number [1] 294071 0
2015/118

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

Contacts
Principal investigator
Name 62314 0
Dr Mehmet SARGIN
Address 62314 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 62314 0
Turkey
Phone 62314 0
+905322662766
Fax 62314 0
Email 62314 0
[email protected]
Contact person for public queries
Name 62315 0
Sadik OZMEN
Address 62315 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 62315 0
Turkey
Phone 62315 0
+903322212250
Fax 62315 0
Email 62315 0
[email protected]
Contact person for scientific queries
Name 62316 0
Sadik OZMEN
Address 62316 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 62316 0
Turkey
Phone 62316 0
+903322212250
Fax 62316 0
Email 62316 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.