Trial Outcomes & Findings for Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients (NCT NCT00757822)

NCT ID: NCT00757822

Last Updated: 2016-05-13

Results Overview

The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 216 participants
• Primary outcome timeframe: 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)
• Results posted on: 2016-05-13

Participant Flow

Recruitment period was from 12-02-2009 to 11-20-2013. Participants were recruited during pre-surgery or preanesthesia clinic visits for elective outpatient abdominal surgery lasting at least 1 hr. Inclusion criteria included high risk for post-operative nausea and vomiting (PONV) as measured by a Koivuranta score (K score) of 2 or more.

36 participants were withdrawn prior to assignment into a treatment arm: 8 participants voluntarily withdrew prior to surgery date, 2 did not meet inclusion criteria, 6 had exclusion criteria, 3 withdrawn when study was closed to enrollment, 17 were withdrawn due to cancellation or re-scheduled surgery incompatible with study schedules.

Participant milestones

Measure	Arm 1: Dronabinol dronabinol Dronabinol: Dronabinol (5mg) will be administered po 30-60 min prior start of surgery.	Arm 2: Ondansetron ondansetron Ondansetron: Ondansetron (4 mg) will be administered iv 20-30 min prior to end of surgery in those patients not receiving Dronabinol.
Overall Study STARTED	92	88
Overall Study Day of Surgery (DOS) Assessment	92	88
Overall Study Withdrawal by Subject-no Intervention	1	3
Overall Study DOS Withdrawn by Investigator	6	11
Overall Study Received Study Intervention	85	74
Overall Study DOS: Post-operative Assessments	85	74
Overall Study 24-48 hr Telephone Assessment	85	74
Overall Study 2-6 wk Post-op Assessment	85	74
Overall Study Data Entry, QC Assessment	85	74
Overall Study Withdrawn-low-risk for PONV	12	9
Overall Study Withdrawn-protocol Deviation	9	8
Overall Study Data Lock, Unblinding Analysis	64	57
Overall Study COMPLETED	64	57
Overall Study NOT COMPLETED	28	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1: Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2: Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.	Total n=121 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 12.5 • n=5 Participants	57.6 years STANDARD_DEVIATION 13.2 • n=7 Participants	57.7 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	55 Participants n=7 Participants	114 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	48 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Risk scores for PONV K score=2	44 participants n=5 Participants	35 participants n=7 Participants	79 participants n=5 Participants
Risk scores for PONV K score >2	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Population: Per protocol

The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Incidence of Postoperative Nausea and Vomiting Incidence PACU PON	34.4 percentage of participants	29.8 percentage of participants
Incidence of Postoperative Nausea and Vomiting Incidence PACU POV	12.5 percentage of participants	7 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale Moderate Nausea (VAS score =4-6)	7.8 percentage of participants	1.8 percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale Severe nausea (VAS score=7-9)	7.8 percentage of participants	7.0 percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale Extreme nausea (VAS score=10)	9.4 percentage of participants	8.8 percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale No nausea (VAS score=0)	59.4 percentage of participants	70.2 percentage of participants
Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale Mild Nausea (VAS score=1-3)	15.6 percentage of participants	12.3 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery 24-48hr PON incidence	23.4 percentage of participants	22.8 percentage of participants
Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery 24-48 hr POV incidence	6.3 percentage of participants	3.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Post-Operative Care Unit Length of Stay (Min)	99.5 minutes Interval 73.0 to 139.0	97.0 minutes Interval 70.0 to 150.0

SECONDARY outcome

Timeframe: Post-operative Day of Surgery (DOS)

Number of all-cause hospital admissions on day of elective out-patient surgery .

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure DOS admission-observation	3 participants	3 participants
Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure DOS admission- urinary retension	4 participants	3 participants
Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure DOS admission-pain management	1 participants	1 participants
Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure DOS admission- low SpO2	1 participants	0 participants
Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure DOS admission -intractable nausea/vomitting	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Post-operative Antiemetic Use Medication need during PACU stay	25 percentage of participants	17 percentage of participants
Post-operative Antiemetic Use Medication need for first 48 hrs after discharge t	3 percentage of participants	4 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting 24-48 hr post-operative interview	92 percent of participants	89 percent of participants
Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting 2-6 week post-operative interview	87 percent of participants	75 percent of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Arm 1:Dronabinol n=64 Participants dronabinol Dronabinol: Dronabinol (5mg) will be administered po 20-60 min pre-operatively.	Arm 2:Ondansetron n=57 Participants ondansetron Ondansetron: Ondansetron (4mg) will be administered iv intraoperatively in those patients not receiving Dronabinol.
Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication 24-48 hr. post-op	80 percent of participants	70 percent of participants
Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication 2-6 wk post-op	73 percent of participants	68 percent of participants

Adverse Events

Dronabinol- Experimental Therapy

Serious events: 13 serious events

Other events: 2 other events

Deaths: 0 deaths

Ondansetron-control Therapy

Serious events: 10 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dronabinol- Experimental Therapy n=92 participants at risk Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.	Ondansetron-control Therapy n=88 participants at risk Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
Surgical and medical procedures overnight hospitalization secondary to unanticipated extensive surgery	3.3% 3/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	3.4% 3/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Surgical and medical procedures overnight hospitalization secondary to urinary retention	4.3% 4/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	3.4% 3/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Surgical and medical procedures overnight hospitalization secondary to excessive postoperative pain	2.2% 2/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	1.1% 1/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Respiratory, thoracic and mediastinal disorders post-operative overnight hospitalization secondary to low sPO2	1.1% 1/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	0.00% 0/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Surgical and medical procedures post-operative complication due to surgery	3.3% 3/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	0.00% 0/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Gastrointestinal disorders hospitalization due to co-morbid preexisting conditions	0.00% 0/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	2.3% 2/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.
Cardiac disorders hospitilization due to co-morbid preexisting conditions	0.00% 0/92 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	1.1% 1/88 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.

Other adverse events

Measure	Dronabinol- Experimental Therapy n=92 participants at risk Dronabinol (5mg) was administered po 30-60 min prior to start of elective abdominal surgery scheduled for same day discharge to home.	Ondansetron-control Therapy n=88 participants at risk Ondansetron (4 mg) was administered iv 20-30 min prior to end of elective abdominal surgery scheduled for same day discharge to home.
Surgical and medical procedures Swelling at incision site	2.2% 2/92 • Number of events 2 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.	6.8% 6/88 • Number of events 6 • 1-72 days post-surgery (e.g. 30 days post last follow-up visit at 2-6 weeks) Participant medical chart review at 2-6 weeks post operation follow-up assessment and at weekly intervals up to 30 days after last follow-up/end of participation in study.

Additional Information

Dr. Muhammad Jaffar

Central Arkansas Veterans Healthcare System

Phone: 501-688-9310

Email: Muhammad.Jaffar@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place