NCT06727201

Brief Summary

The objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
9mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress65%
Jan 2025Feb 2027

First Submitted

Initial submission to the registry

November 28, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

November 28, 2024

Last Update Submit

December 6, 2024

Conditions

Spinal Anaesthesia Induced Hypotension

Keywords

OndansetronSpinal anaethesiaHypotensionNorepinephrine

Outcome Measures

Primary Outcomes (1)

  • Total consumption of norepinephrine during the whole surgical procedure.

    Comparison between total amount of vassopressor used to maintain normal blood pressure in both groups of study

    Just after subarachnoid block till the end of surgery

Secondary Outcomes (1)

  • Incidence of hypotension, hemodynamic data and postoperative complications(nausea,vomiting,hypertension and bradycardia).

    Just after subarachnoid block till 24 hours postoperative

Study Arms (2)

Ondansetron (Zofran)

ACTIVE COMPARATOR

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot

Drug: Ondansetron (Zofran)

Saline placebo

PLACEBO COMPARATOR

Normal saline will be administered by intravenous infusion 10 minutes before spinal anaesthesia

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Ondansetron (Zofran)DRUG

Ondansetron will be given intravenously in a dose of 0.1mg/kg 10 minutes before spinal anaesthesia as single shot.

Ondansetron (Zofran)
Saline (NaCl 0,9 %) (placebo)DRUG

normal saline infusion will be given intravenously 10 minutes before spinal anaesthesia

Saline placebo

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 19 to 40 years old.
  • Singleton pregnancies with a gestational age of at least 37 weeks.
  • pregnant women are scheduled for elective caesarean delivery.
  • Patients with stable vital signs.
  • Patients with normal laboratory investigations.
  • patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorizaion of the uterus.

You may not qualify if:

  • Patient's refusal.
  • Age \< 19 or \> 40 years.
  • Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
  • Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
  • Patients with cardiac morbidities.
  • hypertensive disorders of pregnancy as pre-eclampsia.
  • peripartum bleeding.
  • Patients with respiratory morbidities.
  • Convulsions.
  • Bleeding diathesis.
  • Known allergy to any drugs used in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (1)

  • Sheng ZM, Sun HQ, Mao JQ, Liu J, Liang G, Mei Z. Comparative dose-response study on the infusion of norepinephrine combined with intravenous ondansetron versus placebo for preventing hypotension during spinal anesthesia for cesarean section: a randomised controlled trial. Int J Surg. 2024 Feb 1;110(2):832-838. doi: 10.1097/JS9.0000000000000920.

    PMID: 38000073RESULT

MeSH Terms

Conditions

Hypotension

Interventions

OndansetronSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mohamed H Bakri, professor

    Assiut University

    STUDY DIRECTOR

  • Ola M Wahba, A.professor

    Assiut University

    STUDY DIRECTOR

  • Abdelrahman H Mohammed, A.professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Waleed T Farouk, Resident

CONTACT

+2001150903140Waleedtarek523@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 10, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations

EG(1)