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Trial registered on ANZCTR


Registration number
ACTRN12613000036718
Ethics application status
Approved
Date submitted
11/01/2013
Date registered
14/01/2013
Date last updated
18/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
the effect of ondansetron on hypotension due to spinal anesthesia for caesarean section.
Scientific title
spinal-induced hypotension reduction with ondansetron
in parturients undergoing caesarean section: A double-blind
randomised, controlled study.
Secondary ID [1] 281754 0
nil
Universal Trial Number (UTN)
U1111-1138-4350
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension induced by spinal anesthesia for caeserean section 288065 0
Condition category
Condition code
Anaesthesiology 288436 288436 0 0
Other anaesthesiology
Reproductive Health and Childbirth 288444 288444 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 mg ondansetron (4 milliliters) given intravenously, 5 minutes before spinal anesthesia (using 10 mg hyperbaric bupivacaine 0.5% plus 2.5 microgramm sufentanil)
Intervention code [1] 286292 0
Treatment: Drugs
Comparator / control treatment
4 milliliters of saline solution given intravenously, 5 minutes before spinal anesthesia (using 10 mg hyperbaric bupivacaine 0.5% plus 2.5 microgramm sufentanil)
Control group
Placebo

Outcomes
Primary outcome [1] 288604 0
diastolic blood pressure.
Timepoint [1] 288604 0
baseline time (before injection of ondonsetron or saline),at the end of spinal injection and every 5 minutes until end of surgey.
non invasive blood pressure



Primary outcome [2] 288613 0
neonates pH
Timepoint [2] 288613 0
at delivery.

arterial blood gas from umbilical cord
Primary outcome [3] 288614 0
heart rate
Timepoint [3] 288614 0
baseline time (before injection of ondonsetron or saline),at the end of spinal injection and every 5 minutes until end of surgey.

electrocardioscope
Secondary outcome [1] 300575 0
maternal oxygen saturation
Timepoint [1] 300575 0
at time of spinal injection and at 5-min intervals until the end of surgery

pulse oxymetry
Secondary outcome [2] 300576 0
Upper sensory levels

pinkprick and cold test
Timepoint [2] 300576 0
5-min intervals from spinal injection to 10 minutes
Secondary outcome [3] 300577 0
Nausea and vomiting and pruritis

spontaneous reporting, clinical manifestations (retching, vomiting or itching) and any request for antiemiting or antihistaminic medications
Timepoint [3] 300577 0
when occured until 2 days after surgery
Secondary outcome [4] 300593 0
systolic blood pressure
Timepoint [4] 300593 0
baseline time (before injection of ondonsetron or saline),at the end of spinal injection and every 5 minutes until end of surgey.

non invasive blood pressure
Secondary outcome [5] 300594 0
mean blood pressure
Timepoint [5] 300594 0
baseline time (before injection of ondonsetron or saline),at the end of spinal injection and every 5 minutes until end of surgey.

non invasive blood pressure
Secondary outcome [6] 300595 0
maternal lactates
Timepoint [6] 300595 0
basliene time (before injection of ondonsetron or saline) and at cutaneous incision

arterial blood gas
Secondary outcome [7] 300596 0
apgar score
Timepoint [7] 300596 0
at 1,3,5 and 10 minutes after birth

Eligibility
Key inclusion criteria
parturients ,who were ASA physical status I, undergoing an elective caesarean section
Minimum age
20 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parturients with contraindications to subarachnoid block
(patient refusal, unstable haemodynamics, coagulation
abnormality), history of hypersensitivity to ondansetron or local anaesthetic agents, hypertensive disorders of
pregnancy, cardiovascular insufficiency and parturients receiving selective serotonin reuptake inhibitors

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)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4786 0
Tunisia
State/province [1] 4786 0
TUNIS

Funding & Sponsors
Funding source category [1] 286540 0
Hospital
Name [1] 286540 0
Tunisian Military Hospital
Address [1] 286540 0
20 Montfleury street; 1002 Tunis; TUNISIA
Country [1] 286540 0
Tunisia
Primary sponsor type
Hospital
Name
Tunisian Military Hospital
Address
20 Montfleury street; 1002 Tunis; TUNISIA
Country
Tunisia
Secondary sponsor category [1] 285327 0
None
Name [1] 285327 0
Address [1] 285327 0
Country [1] 285327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288609 0
Tunisian Military Hospital local ethic committee
Ethics committee address [1] 288609 0
20 Montfleury street 1002 Tunis; TUNISIA
Ethics committee country [1] 288609 0
Tunisia
Date submitted for ethics approval [1] 288609 0
14/12/2012
Approval date [1] 288609 0
19/12/2012
Ethics approval number [1] 288609 0

Summary
Brief summary
spinal-induced hypotension results primarily from decreased vascular resistance secondary to a relative parasympathetic dominance, increased baroreceptor activity, or induction of the Bezold Jarisch Reflex (BJR). several animal studies
suggest that 5-HT (serotonin) may be an important factor
associated inducing the BJR.
We hypothesized that spinal-induced
hypotension and bradycardia could be minimized
with the use of intravenous ondansetron, a 5-HT3 receptor
antagonist, in obstetric patients undergoing caesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36742 0
A/Prof Trabelsi walid
Address 36742 0
departement of anesthesia and intensive care unit, Tunisian Military Hospital, 20 Montfleury street 1002 Tunis; TUNISIA
Country 36742 0
Tunisia
Phone 36742 0
+216 24091983
Fax 36742 0
Email 36742 0
walid_trabelsi2009@yahoo.fr
Contact person for public queries
Name 36743 0
A/Prof Trabelsi walid
Address 36743 0
departement of anesthesia and intensive care unit, Tunisian Military Hospital, 20 Montfleury street 1002 Tunis; TUNISIA
Country 36743 0
Tunisia
Phone 36743 0
+216 24091983
Fax 36743 0
Email 36743 0
walid_trabelsi2009@yahoo.fr
Contact person for scientific queries
Name 36744 0
A/Prof Trabelsi walid
Address 36744 0
departement of anesthesia and intensive care unit, Tunisian Military Hospital, 20 Montfleury street 1002 Tunis; TUNISIA
Country 36744 0
Tunisia
Phone 36744 0
+216 24091983
Fax 36744 0
Email 36744 0
walid_trabelsi2009@yahoo.fr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary