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
Necmettin Erbakan University Meram School of Medicine, Akyokus, Meram-Konya 42080
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
Sixty patients between the ages of 18-65 yr, ASA physical status I and II, scheduled to undergo routine outpatient surgery under general anesthesia, were studied. Exclusion criteria included 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.
The patients were randomized, by using a computer-generated block randomisation, into 2 groups: Group C (n=30) 0.9 % sodium chloride, Group H (n=30) Hyoscine N-butylbromide 20 mg. Both placebo (0.9 % sodium chloride) and Hyoscine N-butylbromide were prepared in identical syringes by an anesthesia nurse who were blind to study. For each patient, study team personnel received a syringe and a data collection sheet, both labeled with the study subject number.
In all patients, a 20-gauge intravenous cannula was inserted in the radial vein at the wrist of the right hand for intravenous (IV) fluids and medication administration. After applying routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff ) and providing pre-oxygenation in the operating room, the assigned study drug was injected by bolus over 2–3 seconds. The intravenous line containing lactated ringers solution was then allowed to flow freely. After twenty seconds, a 50-mg dose of propofol at room temperature was injected by bolus over 2–3 seconds, followed again by free flow of the lactated ringers solution. Ten seconds following the injection of propofol, each patient was asked a standard question about pain on injection (‘‘Are you having pain at your IV site?’’) and their responses were noted by an anesthesiologist, who was blinded to study. 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).
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
mehmet21sargin@yahoo.com
Contact person for public queries
Name 62315 0
Prof 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
sadikozmen@hotmail.com
Contact person for scientific queries
Name 62316 0
Prof 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
sadikozmen@yahoo.com

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No Supporting Document Provided



Results publications and other study-related documents

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