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Trial registered on ANZCTR


Registration number
ACTRN12624000248561
Ethics application status
Approved
Date submitted
12/12/2023
Date registered
13/03/2024
Date last updated
13/03/2024
Date data sharing statement initially provided
13/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of ondansetron as an adjunct to lidocaine compared with lidocaine pretreatment in reducing pain on propofol injection: A randomized controlled trial
Scientific title
The efficacy of ondansetron as an adjunct to lidocaine compared with lidocaine pretreatment in reducing pain on propofol injection: A randomized controlled trial.
Secondary ID [1] 311157 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain on propofol injection 332321 0
Condition category
Condition code
Anaesthesiology 329031 329031 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20mg lidocaine (2% preservative-free) with 4mg ondansetron was prepared and was administered intravenously at the 3-way stop cock in 5 seconds by the nurse then the 3-way stop cock was locked for 15 seconds before 50 mg of propofol was administered in 5 seconds by the anesthesiologist.
Intervention code [1] 327598 0
Treatment: Drugs
Comparator / control treatment
20mg lidocaine (2% preservative-free) was prepared and was administered intravenously at the 3-way stop cock in 5 seconds by the nurse then the 3-way stop cock was locked for 15 seconds before 50 mg of propofol was administered in 5 seconds by the anesthesiologist.
Control group
Active

Outcomes
Primary outcome [1] 336840 0
Pain on propofol injection
Timepoint [1] 336840 0
immediately after injection of propofol
Secondary outcome [1] 429800 0
Pain on propofol injection
Timepoint [1] 429800 0
20 seconds after injection of propofol
Secondary outcome [2] 429801 0
adverse effects of ondansetron
Timepoint [2] 429801 0
After injection until leave PACU
Secondary outcome [3] 431506 0
adverse effects of lidocaine
Timepoint [3] 431506 0
After injection until leave PACU

Eligibility
Key inclusion criteria
-ASA classification I-II
-scheduled for elective surgery with general anesthesia
-Age 18- 60 years old
-Weight more than 50 kg.
-cooperate and able to communicate
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-patient's refusal
-did not use propofol as induction agent
-IV catheter 20G can't be accessed
-local infection at IV site
-Allergic to ondansetron or lidocaine
-History of cardiac arrhythmia
-unable to assess the pain score
-chronic pain or receive analgesic 24 hours before surgery
-RSI technique was used

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)
sealed envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a randomisation table created by computer software (i.e. computerised sequence generation), Block of 4
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/08/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
260
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 26030 0
Thailand
State/province [1] 26030 0
Bangkok

Funding & Sponsors
Funding source category [1] 315411 0
Hospital
Name [1] 315411 0
King Chulalongkorn Memorial Hospital
Country [1] 315411 0
Thailand
Primary sponsor type
Hospital
Name
King Chulalongkorn Memorial Hospital
Address
none
Country
Thailand
Secondary sponsor category [1] 317475 0
None
Name [1] 317475 0
Address [1] 317475 0
Country [1] 317475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314326 0
The Institutional Review Board of the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand,
Ethics committee address [1] 314326 0
Ethics committee country [1] 314326 0
Thailand
Date submitted for ethics approval [1] 314326 0
19/04/2023
Approval date [1] 314326 0
22/06/2023
Ethics approval number [1] 314326 0

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

Contacts
Principal investigator
Name 131198 0
Ms Lucksamon Sirivichayakul
Address 131198 0
Department of Anesthesiology, Faculty of Medicine , Chulalongkorn University, 1873 Rama IV Rd. Patumwan Patumwan Bangkok Thailand
Country 131198 0
Thailand
Phone 131198 0
+66825586332
Fax 131198 0
Email 131198 0
lucksamon.sir@gmail.com
Contact person for public queries
Name 131199 0
Lucksamon Sirivichayakul
Address 131199 0
Department of Anesthesiology, Faculty of Medicine , Chulalongkorn University, 1873 Rama IV Rd. Patumwan Patumwan Bangkok Thailand
Country 131199 0
Thailand
Phone 131199 0
+66825586332
Fax 131199 0
Email 131199 0
lucksamon.sir@gmail.com
Contact person for scientific queries
Name 131200 0
Lucksamon Sirivichayakul
Address 131200 0
Department of Anesthesiology, Faculty of Medicine , Chulalongkorn University, 1873 Rama IV Rd. Patumwan Patumwan Bangkok Thailand
Country 131200 0
Thailand
Phone 131200 0
+66825586332
Fax 131200 0
Email 131200 0
lucksamon.sir@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.