Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001235594
Ethics application status
Approved
Date submitted
28/07/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Could antivomiting agent ondansetron prevent low blood pressure during spinal anesthesia for caesarean section?
Scientific title
Efficacy of ondansetron in preventing hypotension during spinal anaesthesia for caesarean section
Secondary ID [1] 312626 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension during spinal anaesthesia 334579 0
caesarean section 334589 0
Condition category
Condition code
Reproductive Health and Childbirth 331177 331177 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal anaesthesia will be performed for elective caesarean section. The procedure will be performed in sitting position. Atraumatic spinal Whitacre needle, 27-gauge, 9 mm of length will be employed. The level of puncture by spinal needle will be between third and fourth or fourth and fifth lumbar vertebra. Upon confirmation of cerebrospinal fluid flow, the mixture of hyperbaric 0,5% bupivacaine, 25 mcg of fentanyl and 150 mcg of morphine will be administered intrathecally. Depending on pateint's height, eight (in case that height is less than 165 cm) or ten miligrams of 0.5% hyperbaric bupivacaine will be given. Participants will be randomly assigned in one of three groups, namely control group and in two interventional groups. Participant in arm 2 will receive 4 mg (2 ml) of ondansetron intravenously diluted with 8 ml of saline in 10 ml syringe, while study participants in arm 3 will be given 8 mg (4ml) of ondansetron intravenously, diluted with 6 ml of saline in 10 ml syringe. Both interventional groups (arm 2 and arm3) will receive ondansetron 5 minutes before commencement of spinal anaesthesia procedure. The study drug will be previously prepared by anaesthesia resident, while attending anaesthesiologist will be unaware of syringe content. All participants in all three arms will receive 10 mg of metoclopramide intravenously after completion of intrathecal drug administration. All drugs administered in operating theatre during anesthesia will be recorded by anaesthesia resident.
Intervention code [1] 329144 0
Treatment: Drugs
Intervention code [2] 329145 0
Prevention
Comparator / control treatment
Spinal anaesthesia will be performed for elective caesarean section. The procedure will be performed in sitting position. Atraumatic spinal Whitacre needle, 27-gauge, 9 mm of length will be employed. The level of puncture by spinal needle will be between third and fourth or fourth and fifth lumbar vertebra. Upon confirmation of cerebrospinal fluid flow, the mixture of hyperbaric 0,5% bupivacaine, 25 mcg of fentanyl and 150 mcg of morphine will be administered intrathecally. Depending on pateint's height, eight (in case that height is less than 165 cm) or ten miligrams of 0.5% hyperbaric bupivacaine will be given. Five minutes before spinal anaethesia commencement, 10 ml of saline, prepared in 10 ml syringe will be administered intavenously. The study drug will be previously prepared by anaesthesia resident, while attending anaesthesiologist will be unaware of syringe content. All participants in all three arms will receive 10 mg of metoclopramide intravenously after completion of intrathecal drug administration.
Control group
Placebo

Outcomes
Primary outcome [1] 338939 0
Primary outcome is the incidence of hypotension in period from intrathecal drug administration until delivery.
Timepoint [1] 338939 0
Blood pressure will be noninvasively measured and recoreded at the time of spinal block and at 3 minutes interval during the period from spinal anaesthesia initiation until delivery.
Primary outcome [2] 339322 0
Overall administration of vasoactive drugs ( ephedrine, phenylephrine and atropine) during spinal anaesthesia.
Timepoint [2] 339322 0
The number of vasoactive drug boluses administered from intrathecal drug administration until delivery.
Secondary outcome [1] 437964 0
The occurrence of pruritus will be assessed postoperatively.
Timepoint [1] 437964 0
Pruritus will be assessed upon completion of surgery and at 2 hours interval up to six hours postoperatively.
Secondary outcome [2] 439451 0
Occurrence of shivering in postoperative period.
Timepoint [2] 439451 0
The shivering will be assessed upon completion of surgery and at 2 hours interval up to six hours postoperatively.

Eligibility
Key inclusion criteria
Healty parturients scheduled for caesarean section in spinal anaesthesia
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Preeclampsia, eclampsia, contraindications for neuroaxial anesthesia (coagulopathies, infection at puncture site, aortic valve stenosis, central nervous system disorders).

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

Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis
Kolmogorov-Smirnov test will be deployed to test normality of distribution for quantitative data. Dependent on type of distribution, parametric or nonparametric tests will be used for comparison. Comparison of nominal data will be done by chi square test. Mann-Whitney U test will be applied for ordinal data as well as for continuous data with asymmetrical distribution. Student's t test will be used for continuous data with normal distribution. p value less than 0.05 is considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 26477 0
Croatia
State/province [1] 26477 0

Funding & Sponsors
Funding source category [1] 317062 0
Hospital
Name [1] 317062 0
University Hospital Centre Sestre milosrdnice
Country [1] 317062 0
Croatia
Primary sponsor type
Individual
Name
Iva Pažur- University Hospital Centre Sestre milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 319310 0
None
Name [1] 319310 0
Address [1] 319310 0
Country [1] 319310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315811 0
Ethical Committee of University Hospital Clinical Centre Sestre Milosrdnice
Ethics committee address [1] 315811 0
Ethics committee country [1] 315811 0
Croatia
Date submitted for ethics approval [1] 315811 0
03/06/2024
Approval date [1] 315811 0
12/06/2024
Ethics approval number [1] 315811 0

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

Contacts
Principal investigator
Name 135878 0
Dr Iva Pažur
Address 135878 0
University Hospital Centre Sestre milosrdnice, Department of Anaesthesiology, Intensive Medicine and Pain Management, Vinogradska street 29, 10000 Zagreb, Croatia
Country 135878 0
Croatia
Phone 135878 0
+385 91 6050 924
Fax 135878 0
Email 135878 0
[email protected]
Contact person for public queries
Name 135879 0
Iva Pažur
Address 135879 0
University Hospital Centre Sestre milosrdnice, Department of Anaesthesiology, Intensive Medicine and Pain Management, Vinogradska cesta 29, Zagreb, Croatia
Country 135879 0
Croatia
Phone 135879 0
+385 91 6050 924
Fax 135879 0
Email 135879 0
[email protected]
Contact person for scientific queries
Name 135880 0
Iva Pažur
Address 135880 0
University Hospital Centre Sestre milosrdnice, Department of Anaesthesiology, Intensive Medicine and Pain Management, Vinogradska street 29, 10000 Zagreb, Croatia
Country 135880 0
Croatia
Phone 135880 0
+385 91 6050 924
Fax 135880 0
Email 135880 0
[email protected]

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.