Skip to main content
OpenTrials
Completed

NCT Number: NCT05759481

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post-operative Nausea and Vomiting Motion Sickness Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing general anesthesia for elective surgery
  • Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
  • No documented allergy/adverse reaction to propofol
  • English speaking
  • At least 18 years of age

Exclusion criteria

  • Any anti-nausea medication taken within 24 hours prior to surgery
  • Unable to provide consent independently
  • Allergy or adverse reaction to propofol
  • Emergency surgery

Treatment and study plan

Hybrid anesthesia (propofol + sevoflurane)

Drug

General anesthesia maintained with a continuous low-dose propofol infusion (25 mcg/kg/min) combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted.

Propofol only TIVA

Drug

General anesthesia maintained exclusively with intravenous propofol infusion, without the use of volatile anesthetics. Propofol dosing was titrated to maintain a bispectral index (BIS) target of 40-60. No other hypnotic or sedative agents were permitted

Primary outcomes

  1. Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)

    Time frame: 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.

Secondary outcomes

  1. Episodes of Post Operative Nausea/Vomiting (PONV)

    Time frame: 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.

  2. Use of Antiemetics

    Time frame: 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.

Other outcomes

  1. Number of Subjects Experiencing Nausea.

    Time frame: PACU upto 23 hrs.

    The number of subjects self-reported nausea episodes.

  2. Number of Subjects Experiencing Retching.

    Time frame: PACU upto 23 hrs

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

  3. Vomiting (Forceful Expulsion of Gastric Contents) Episodes

    Time frame: 24 hours

    Number of self-reported vomiting episodes

  4. Number of Subjects Receiving Medication for Nausea.

    Time frame: PACU upto 1 hrs

    Number of subjects who received Ondansetron medication for treating nausea.

  5. Number of Subjects Receiving Medication for Nausea - Promethazine

    Time frame: PACU upto 1 hrs.

    Number of subjects receiving promethazine for nausea treatment.

  6. Number of Subjects Receiving Medication for Nausea.- Promethazine.

    Time frame: 24 hours.

    Number of subjects receiving promethazine medication for nausea.

  7. Number of Subjects Who Received Prochlorperazine

    Time frame: PACU upto 1 hr

    medication administered

  8. Number of Subjects Receiving Medication for Nausea - Prochlorperazine

    Time frame: 24 hours

    Number of subjects receiving medication for nausea - prochlopreazine.

  9. Number of Subjects Receiving Droperidol

    Time frame: PACU upto 1 hr

    medication administered

  10. Number of Subject Receiving Scopolamine Patch

    Time frame: 24 hours

    medication administered

  11. Number of Subjects Experiencing Nausea (Urge to Vomit Episodes)

    Time frame: 24 hours

    Number of subjects experiencing nausea.

  12. Number of Subjects Experiencing Retching Contents)

    Time frame: 24 hours

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

  13. Number of Subjected Experiencing Vomiting (Forceful Expulsion of Gastric Contents) Episodes

    Time frame: 24 hours

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

  14. Number of Subjects Receiving Ondansetron

    Time frame: 24 hours

    Number of subjects receiving ondansetron.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Acronym: PONV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2023
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.