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CompletedNCT03297021Updated Jul 20, 2020Results posted

Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

A Phase 4 interventional study of Ondansetron 4 MG and Ondansetron 8mg in Post-operative Nausea and Vomiting, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-20.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Read the detailed description

Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

02

Conditions studied

  • Post-operative Nausea and Vomiting

Keywords

  • ambulatory surgery
  • post-operative nausea and vomiting
  • general anesthesia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Patients with allergies or contraindications to study medications
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
141 participants (actual)

Study arms

  • Placebo comparator
    Ondansetron 4mg Pre-emergence

    Drug: Ondansetron 4 MG

  • Experimental
    Ondansetron 8mg Pre-emergence

    Drug: Ondansetron 8mg

  • Experimental
    Ondansetron Pre-Incision and Pre-emergence

    4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence

    Drug: Ondansetron 4 MG

Interventions

  • DrugOndansetron 4 MG

    dose as per arm selection

  • DrugOndansetron 8mg

    dose as per arm selection

05

What researchers measure

Primary outcomes

  1. Nausea Scale

    Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea

    Time frame: average of 4 hours in PACU and POD1

Secondary outcomes

  1. Number of Participants With Episodes of Vomiting in the PACU

    Number of participants with episodes of vomiting in the Post Anesthesia Care Unit

    Time frame: average of 4 hours

  2. Number of Participants With Symptoms on POD 1

    Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one

    Time frame: Day 1

  3. Number of Participants Who Needed Rescue Anti-emetics

    Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU

    Time frame: average of 4 hours

  4. Total Anesthesia Time

    Time frame: intraoperative, up to 3.5 hours

06

Results

Posted Jul 20, 2020

Participant flow

165 patients assessed for eligibility 141 patients were randomized

Participant flow — Overall Study
MilestoneOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
Started484647
Completed434243
Not completed544
Withdrew: Incomplete/illegible data sheet423
Withdrew: Missing post-op data121

Outcome measures

PrimaryNausea Scale

Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea

Time frame:
average of 4 hours in PACU and POD1
Reported as:
Mean · score on a scale
Nausea Scale
score on a scaleOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
PACU3.5 (1.75 to 4.0)4.0 (3.0 to 6.0)4.0 (1.5 to 6.0)
POD12.0 (1.0 to 3.0)1.0 (1.0 to 5.5)8.0 (8.0 to 8.0)
SecondaryNumber of Participants With Episodes of Vomiting in the PACU

Number of participants with episodes of vomiting in the Post Anesthesia Care Unit

Time frame:
average of 4 hours
Reported as:
Count of participants · Participants
Number of Participants With Episodes of Vomiting in the PACU
ParticipantsOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
Number of Participants With Episodes of Vomiting in the PACU201
SecondaryNumber of Participants With Symptoms on POD 1

Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Participants With Symptoms on POD 1
ParticipantsOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
Nausea941
Vomiting110
Headache553
SecondaryNumber of Participants Who Needed Rescue Anti-emetics

Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU

Time frame:
average of 4 hours
Reported as:
Count of participants · Participants
Number of Participants Who Needed Rescue Anti-emetics
ParticipantsOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
Number of Participants Who Needed Rescue Anti-emetics412
SecondaryTotal Anesthesia Time
Time frame:
intraoperative, up to 3.5 hours
Reported as:
Mean · minutes
Total Anesthesia Time
minutesOndansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergence
Total Anesthesia Time116.0 (93.0 to 178.0)128.5 (86.5 to 186.25)118.0 (93.0 to 172.0)

Adverse events

Collected over 1 day. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ondansetron 4mg Pre-emergence0/43 (0%)0/43 (0%)0/43 (0%)
Ondansetron 8mg Pre-emergence0/42 (0%)0/42 (0%)0/42 (0%)
Ondansetron Pre-Incision and Pre-emergence0/43 (0%)0/43 (0%)0/43 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Median40 (33 to 51)39 (30 to 51)48 (31 to 57)40 (30 to 57)
Sex: Female, Male
Sex: Female, Male(Participants)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Female413637114
Male26614
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Count of participants———0
ASA Class
ASA Class(units on a scale)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Median1 (1 to 2)1 (1 to 2)1 (1 to 2)1 (1 to 2)
BMI
BMI(kg/m^2)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Median24.0 (21.0 to 27.0)25.0 (22.0 to 29.2)24.0 (21.0 to 28.6)24 (21 to 29.2)
History of PONV
History of PONV(Participants)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Count of participants1281333
History of Vertigo
History of Vertigo(Participants)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Count of participants1124
History of Motion Sickness
History of Motion Sickness(Participants)Ondansetron 4mg Pre-emergenceOndansetron 8mg Pre-emergenceOndansetron Pre-Incision and Pre-emergenceTotal
Count of participants13101740

1 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 14, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03297021
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Daniel Katz (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Sep 29, 2017
Start date
Oct 23, 2017
Primary completion
Apr 5, 2019
Completion
Apr 5, 2019
Results posted
Jul 20, 2020
Last update
Jul 20, 2020

Study contacts

Daniel Katz, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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