Trial Review

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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
1873 Rama IV Rd. Patumwan Patumwan Bangkok Thailand 10330
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
Ondansetron was proved to decrease pain on propofol injection. Lidocaine also has a role on pain on propofol injection. This study is aimed to determine efficacy of ondansetron as an adjunct to lidocaine in pain on propofol injection compared with lidocaine alone.
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
Ms 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
Ms 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.