Trial Outcomes & Findings for Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion (NCT NCT05759481)

Results Overview

Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

24 hours

Results posted on

2026-08-14

Participant Flow

Participants were recruited between February 2024 and March 2025 at a single academic tertiary-care center (Penn State Health Milton S. Hershey Medical Center). Recruitment occurred in the preoperative surgical setting for adult patients scheduled for elective laparoscopic surgery under general anesthesia, including general, gynecologic, and urologic procedures.

After written informed consent, participants were randomized prior to induction of anesthesia using a computer-based randomization tool. Allocation occurred as planned, with no delays, protocol deviations, or participant withdrawals during this interval.

Participant milestones

Participant milestones
Measure	Hybrid Group Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA Propofol infusion with infusion titrated to BIS 40-60
Overall Study STARTED	32	33
Overall Study COMPLETED	32	31
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Hybrid Group Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA Propofol infusion with infusion titrated to BIS 40-60
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60	Total n=65 Participants Total of all reporting groups
Sex: Female, Male Male	5 Participants n=32 Participants	3 Participants n=33 Participants	8 Participants n=65 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI, kg/m²)	29.5 kg/m² n=32 Participants	29 kg/m² n=33 Participants	29.25 kg/m² n=65 Participants
Age, Continuous	40.5 years n=32 Participants	40 years n=33 Participants	40.25 years n=65 Participants
Sex: Female, Male Female	27 Participants n=32 Participants	30 Participants n=33 Participants	57 Participants n=65 Participants
Number of smokers	2 Participants n=32 Participants	1 Participants n=33 Participants	3 Participants n=65 Participants
ASA physical status ASA I	0 Participants n=32 Participants	1 Participants n=33 Participants	1 Participants n=65 Participants
ASA physical status ASA II	19 Participants n=32 Participants	26 Participants n=33 Participants	45 Participants n=65 Participants
ASA physical status ASA III	13 Participants n=32 Participants	6 Participants n=33 Participants	19 Participants n=65 Participants

PRIMARY outcome

Timeframe: 24 hours

Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)	19 Participants	14 Participants

SECONDARY outcome

Timeframe: PACU

PONV in the post-anesthesia care unit (PACU) was defined as any episode of nausea, retching, or vomiting occurring between PACU admission and discharge. Events were documented by PACU nursing staff as part of routine postoperative care.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Episodes of Post Operative Nausea/Vomiting (PONV)	9 episodes	7 episodes

SECONDARY outcome

Timeframe: 24 hours

Use of rescue antiemetics was defined as administration of any antiemetic medication beyond standardized prophylaxis (dexamethasone and ondansetron), either during the post-anesthesia care unit (PACU) stay or within 24 hours after surgery. Antiemetic use was obtained from the medical record in the PACU and from patient self-report during standardized follow-up at 24 hours postoperatively. The outcome was analyzed as a categorical variable and reported as the number and percentage of participants requiring rescue antiemetics.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Use of Antiemetics	9 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 23 hrs.

The number of subjects self-reported nausea episodes.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Experiencing Nausea.	9 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 23 hrs

Number of self-reported retching episodes (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents)

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Experiencing Retching.	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of self-reported vomiting episodes

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 1 hrs

Number of subjects who received Ondansetron medication for treating nausea.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Medication for Nausea.	4 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 1 hrs.

Number of subjects receiving promethazine for nausea treatment.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Medication for Nausea - Promethazine	5 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours.

Number of subjects receiving promethazine medication for nausea.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Medication for Nausea.- Promethazine.	6 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 1 hr

medication administered

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Who Received Prochlorperazine	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of subjects receiving medication for nausea - prochlopreazine.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Medication for Nausea - Prochlorperazine	1 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: PACU upto 1 hr

medication administered

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Droperidol	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

medication administered

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subject Receiving Scopolamine Patch	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of subjects experiencing nausea.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Experiencing Nausea (Urge to Vomit Episodes)	30 participants	50 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of subjects who experienced retching and self-reported it. (labored, spasmodic, rhythmic contractions of respiratory scales without expulsion of gastric episodes

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Experiencing Retching Contents)	3 participants	8 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of subjects experiencing vomiting (forceful expulsion of gastric contents)

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjected Experiencing Vomiting (Forceful Expulsion of Gastric Contents) Episodes	6 participants	19 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Number of subjects receiving ondansetron.

Outcome measures

Outcome measures
Measure	Hybrid Group n=32 Participants Low-dose propofol infusion at 25 mcg/kg/min + sevoflurane titrated to BIS 40-60	Propofol TIVA n=33 Participants Propofol infusion with infusion titrated to BIS 40-60
Number of Subjects Receiving Ondansetron	7 Participants	6 Participants

Adverse Events

Hybrid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol TIVA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Revati Kanekar, Assistant Professor, Dept of Anesthesiology and Perioperative Medicine

Penn State Milton S Hershey Medical Center

Phone: 7175310000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place