Post-operative Nausea and Vomiting
Conditions
Keywords
ambulatory surgery, post-operative nausea and vomiting, general anesthesia
Brief 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.
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.
Interventions
DRUGOndansetron 4 MG
dose as per arm selection
DRUGOndansetron 8mg
dose as per arm selection
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia
Exclusion criteria
* Patients with allergies or contraindications to study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Scale | average of 4 hours in PACU and POD1 | Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Episodes of Vomiting in the PACU | average of 4 hours | Number of participants with episodes of vomiting in the Post Anesthesia Care Unit |
| Number of Participants With Symptoms on POD 1 | Day 1 | Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one |
| Number of Participants Who Needed Rescue Anti-emetics | average of 4 hours | Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU |
| Total Anesthesia Time | intraoperative, up to 3.5 hours | — |
Countries
United States
Participant flow
Recruitment details
165 patients assessed for eligibility 141 patients were randomized
Participants by arm
| Arm | Count |
|---|---|
| Ondansetron 4mg Pre-emergence Ondansetron 4 MG Pre-emergence | 43 |
| Ondansetron 8mg Pre-emergence Ondansetron 8mg Pre-emergence | 42 |
| Ondansetron Pre-Incision and Pre-emergence 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence | 43 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Incomplete/illegible data sheet | 4 | 2 | 3 |
| Overall Study | Missing Post-Op Data | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Ondansetron 4mg Pre-emergence | Ondansetron 8mg Pre-emergence | Ondansetron Pre-Incision and Pre-emergence | Total |
|---|---|---|---|---|
| Age, Continuous | 40 years | 39 years | 48 years | 40 years |
| ASA Class | 1 units on a scale | 1 units on a scale | 1 units on a scale | 1 units on a scale |
| BMI | 24.0 kg/m^2 | 25.0 kg/m^2 | 24.0 kg/m^2 | 24 kg/m^2 |
| Current Smoker | 3 Participants | 0 Participants | 6 Participants | 9 Participants |
| History of Motion Sickness | 13 Participants | 10 Participants | 17 Participants | 40 Participants |
| History of PONV | 12 Participants | 8 Participants | 13 Participants | 33 Participants |
| History of Vertigo | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 41 Participants | 36 Participants | 37 Participants | 114 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 42 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 42 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 | 0 / 43 |
Outcome results
Primary
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
Population: only those participants with nausea completed the nausea scale
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ondansetron 4mg Pre-emergence | Nausea Scale | PACU | 3.5 score on a scale |
| Ondansetron 4mg Pre-emergence | Nausea Scale | POD1 | 2.0 score on a scale |
| Ondansetron 8mg Pre-emergence | Nausea Scale | PACU | 4.0 score on a scale |
| Ondansetron 8mg Pre-emergence | Nausea Scale | POD1 | 1.0 score on a scale |
| Ondansetron Pre-Incision and Pre-emergence | Nausea Scale | PACU | 4.0 score on a scale |
| Ondansetron Pre-Incision and Pre-emergence | Nausea Scale | POD1 | 8.0 score on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ondansetron 4mg Pre-emergence | Number of Participants Who Needed Rescue Anti-emetics | 4 Participants |
| Ondansetron 8mg Pre-emergence | Number of Participants Who Needed Rescue Anti-emetics | 1 Participants |
| Ondansetron Pre-Incision and Pre-emergence | Number of Participants Who Needed Rescue Anti-emetics | 2 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ondansetron 4mg Pre-emergence | Number of Participants With Episodes of Vomiting in the PACU | 2 Participants |
| Ondansetron 8mg Pre-emergence | Number of Participants With Episodes of Vomiting in the PACU | 0 Participants |
| Ondansetron Pre-Incision and Pre-emergence | Number of Participants With Episodes of Vomiting in the PACU | 1 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ondansetron 4mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Vomiting | 1 Participants |
| Ondansetron 4mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Nausea | 9 Participants |
| Ondansetron 4mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Headache | 5 Participants |
| Ondansetron 8mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Vomiting | 1 Participants |
| Ondansetron 8mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Headache | 5 Participants |
| Ondansetron 8mg Pre-emergence | Number of Participants With Symptoms on POD 1 | Nausea | 4 Participants |
| Ondansetron Pre-Incision and Pre-emergence | Number of Participants With Symptoms on POD 1 | Nausea | 1 Participants |
| Ondansetron Pre-Incision and Pre-emergence | Number of Participants With Symptoms on POD 1 | Headache | 3 Participants |
| Ondansetron Pre-Incision and Pre-emergence | Number of Participants With Symptoms on POD 1 | Vomiting | 0 Participants |
Secondary
Total Anesthesia Time
Time frame: intraoperative, up to 3.5 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ondansetron 4mg Pre-emergence | Total Anesthesia Time | 116.0 minutes |
| Ondansetron 8mg Pre-emergence | Total Anesthesia Time | 128.5 minutes |
| Ondansetron Pre-Incision and Pre-emergence | Total Anesthesia Time | 118.0 minutes |