NCT03931863

Brief Summary

The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2.9 years

First QC Date

April 24, 2019

Last Update Submit

January 19, 2021

Conditions

Hypotension

Keywords

ondansetron

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Systolic Blood Pressure during cesarean section

    every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery

    60 minutes

  • Change from Baseline Heart Rate

    every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery

    60 minutes

Secondary Outcomes (15)

  • Sensory blockade

    20 minutes

  • Motor blockade

    20 minutes

  • Sensory regression

    120 minutes

  • Motor block regression

    120 minutes

  • Time to maximum effect (Tmax)

    20 minutes

  • +10 more secondary outcomes

Study Arms (3)

Group A

ACTIVE COMPARATOR

Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Drug: Ondansetron 4mg

Group B

ACTIVE COMPARATOR

Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Drug: Ondansetron 8mg

Group C

PLACEBO COMPARATOR

Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Drug: 100ml normal saline 0.9 percent

Interventions

Ondansetron 4mgDRUG

Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Also known as: Onda
Group A
Ondansetron 8mgDRUG

Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Also known as: Onda
Group B
100ml normal saline 0.9 percentDRUG

Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.

Also known as: N/S 0.9 percent
Group C

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physical status according to American Society of Anesthesiologists (ASA) I-II
  • Singleton pregnant women in full term pregnancy
  • Patients scheduled for cesarean section
  • Height 158cm-170cm

You may not qualify if:

  • patient's own refusal
  • contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
  • ondansetron allergy
  • body mass index\> 33kg / m\^2
  • height \<158cm, or\> 170cm
  • hypertensive disorders of pregnancy
  • cardiovascular disease
  • receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine
  • placenta previa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital, University of Athens

Athens, Attica, 11528, Greece

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Ondansetrononda cryl

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Stavroula Karachanidi

CONTACT

+306970253686skarahanidi@gmail.com

Anteia Paraskeva

CONTACT

+306972868078aparask@med.uoa.gr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All solutions will be prepared by an independent researcher who will not be further involved in the study eg data collecting or analyzing them. All solutions will look identical to the anesthetist who will administer them to the patients.Apart from the anesthetist, the surgery staff and the researchers recording the measurements will not know the therapeutic intervention team in which each patient has been randomized.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 30, 2019

Study Start

May 22, 2019

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

GR(1)