Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Milton S. Hershey Medical Center65 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Post-operative Nausea and Vomiting

Interventions

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 TIVADRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Undergoing general anesthesia for elective surgery 2. Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions 3. No documented allergy/adverse reaction to propofol 4. English speaking 5. At least 18 years of age Exclusion Criteria: 1. Any anti-nausea medication taken within 24 hours prior to surgery 2. Unable to provide consent independently 3. Allergy or adverse reaction to propofol 4. Emergency surgery

Locations (1)

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 24 hours

Secondary Outcomes

Episodes of Post Operative Nausea/Vomiting (PONV)

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.

Time frame: PACU

Use of Antiemetics

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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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