NCT06444737

Brief Summary

A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups: Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia OBJECTIVE : To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

June 6, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 13, 2024

Last Update Submit

June 5, 2024

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.

    the occurrence of positional headaches at any time postoperatively

    7 days

Secondary Outcomes (7)

  • day of PDPH's occurence

    7 days

  • day of PDPH's resolution

    7 days

  • Headache severity

    7 days

  • Need for analgesic treatment due to headaches

    7 days

  • Occurrence of post-operative nausea and/or vomiting

    7 days

  • +2 more secondary outcomes

Study Arms (2)

Group O

EXPERIMENTAL

Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia

Drug: Intravenous ondansetron

Group C

PLACEBO COMPARATOR

Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia

Drug: Intravenous normal saline

Interventions

Intravenous ondansetronDRUG

Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia

Also known as: ondansetron
Group O
Intravenous normal salineDRUG

Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia

Also known as: Placebo
Group C

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparturients scheduled for elective caesarean delivery under spinal anaesthesia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18-45 years
  • ASA 2
  • Between 37 and 41 weeks of gestation
  • scheduled for elective caesarean delivery under spinal anaesthesia
  • To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification

You may not qualify if:

  • All patients who required :
  • more than two attempts for spinal anaesthesia
  • conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level \<T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
  • As well as patients who have subsequently withdrawn their consent for participating to our study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi slim hospital

Tunis, 2085, Tunisia

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Central Study Contacts

Mhamed Sami Mebazaa, professor

CONTACT

22252589msmebazaa@gmail.com

Amani Ben Haj Youssef, assistant

CONTACT

96874336amanibhy@hotmail.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of anesthesiology and ICU department

Study Record Dates

First Submitted

May 13, 2024

First Posted

June 6, 2024

Study Start

November 30, 2023

Primary Completion

June 30, 2024

Study Completion

August 30, 2024

Last Updated

June 6, 2024

Record last verified: 2024-05

Locations

TU(1)