Trial · NCT00757822

Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

NCT00757822, Not applicable, Completed, VA Office of Research and Development; results first posted 2016-05-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients. Trials, record NCT00757822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00757822

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients
NCT number: NCT00757822
Status: Completed
Phases: Not applicable
Enrollment: 216 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Postoperative Nausea and Vomiting
Interventions: Dronabinol, Ondansetron
First posted: 2008-09-23
Last updated: 2016-05-13
Results first posted: 2016-05-13

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Postoperative Nausea and Vomiting	Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)	The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.
Primary	Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit	VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting. VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU.
Primary	Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery	24-48 hrs post surgery	Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.
Secondary	Post-Operative Care Unit Length of Stay (Min)	Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)	Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.
Secondary	Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure	Post-operative Day of Surgery (DOS)	Number of all-cause hospital admissions on day of elective out-patient surgery .
Secondary	Post-operative Antiemetic Use	End of surgery to 48 hr post surgery	Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.
Secondary	Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting	Post operative follow up interviews 24 hrs to 6 wks	Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.
Secondary	Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication	Post-operative follow-up interviews 24 hr to 6 weeks post surgery	Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Postoperative Nausea and Vomiting	Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)	Per protocol	percentage of participants	NUMBER
PRIMARY	Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit		percentage of participants	NUMBER
PRIMARY	Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery	24-48 hrs post surgery		percentage of participants	NUMBER
SECONDARY	Post-Operative Care Unit Length of Stay (Min)	Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)		minutes	MEDIAN
SECONDARY	Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure	Post-operative Day of Surgery (DOS)		participants	NUMBER
SECONDARY	Post-operative Antiemetic Use	End of surgery to 48 hr post surgery		percentage of participants	NUMBER
SECONDARY	Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting	Post operative follow up interviews 24 hrs to 6 wks		percent of participants	NUMBER
SECONDARY	Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication	Post-operative follow-up interviews 24 hr to 6 weeks post surgery		percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Postoperative Nausea and Vomiting	Arm 1:Dronabinol	Incidence PACU PON	34.4	percentage of participants
Incidence of Postoperative Nausea and Vomiting	Arm 2:Ondansetron	Incidence PACU PON	29.8	percentage of participants
Incidence of Postoperative Nausea and Vomiting	Arm 1:Dronabinol	Incidence PACU POV	12.5	percentage of participants
Incidence of Postoperative Nausea and Vomiting	Arm 2:Ondansetron	Incidence PACU POV	7	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 1: Dronabinol	No nausea (VAS score=0)	59.4	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 2:Ondansetron	No nausea (VAS score=0)	70.2	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 1: Dronabinol	Mild Nausea (VAS score=1-3)	15.6	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 2:Ondansetron	Mild Nausea (VAS score=1-3)	12.3	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 1: Dronabinol	Moderate Nausea (VAS score =4-6)	7.8	percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale	Arm 2:Ondansetron	Moderate Nausea (VAS score =4-6)	1.8	percentage of participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: Dronabinol	92
Overall Study	STARTED	Arm 2: Ondansetron	88
Overall Study	Day of Surgery (DOS) Assessment	Arm 1: Dronabinol	92
Overall Study	Day of Surgery (DOS) Assessment	Arm 2: Ondansetron	88
Overall Study	Withdrawal by Subject-no Intervention	Arm 1: Dronabinol	1
Overall Study	Withdrawal by Subject-no Intervention	Arm 2: Ondansetron	3
Overall Study	DOS Withdrawn by Investigator	Arm 1: Dronabinol	6
Overall Study	DOS Withdrawn by Investigator	Arm 2: Ondansetron	11
Overall Study	Received Study Intervention	Arm 1: Dronabinol	85
Overall Study	Received Study Intervention	Arm 2: Ondansetron	74

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Swelling at incision site	Surgical and medical procedures	Dronabinol- Experimental Therapy	2	92	2
other	Swelling at incision site	Surgical and medical procedures	Ondansetron-control Therapy	6	88	6
serious	overnight hospitalization secondary to unanticipated extensive surgery	Surgical and medical procedures	Dronabinol- Experimental Therapy	3	92
serious	overnight hospitalization secondary to unanticipated extensive surgery	Surgical and medical procedures	Ondansetron-control Therapy	3	88
serious	overnight hospitalization secondary to urinary retention	Surgical and medical procedures	Dronabinol- Experimental Therapy	4	92
serious	overnight hospitalization secondary to urinary retention	Surgical and medical procedures	Ondansetron-control Therapy	3	88
serious	overnight hospitalization secondary to excessive postoperative pain	Surgical and medical procedures	Dronabinol- Experimental Therapy	2	92
serious	overnight hospitalization secondary to excessive postoperative pain	Surgical and medical procedures	Ondansetron-control Therapy	1	88
serious	post-operative overnight hospitalization secondary to low sPO2	Respiratory, thoracic and mediastinal disorders	Dronabinol- Experimental Therapy	1	92
serious	post-operative overnight hospitalization secondary to low sPO2	Respiratory, thoracic and mediastinal disorders	Ondansetron-control Therapy	0	88

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dronabinol- Experimental Therapy
Total, all-cause mortality	Ondansetron-control Therapy
Total, other adverse events	Dronabinol- Experimental Therapy	2	92
Total, other adverse events	Ondansetron-control Therapy	6	88
Total, serious adverse events	Dronabinol- Experimental Therapy	13	92
Total, serious adverse events	Ondansetron-control Therapy	10	88

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dronabinol- Experimental Therapy vs Ondansetron-control Therapy: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00757822

GET https://conductscience.org/api/trials/v1/NCT00757822/results?page=2

API reference For AI assistants