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Clinical Trials/NCT05759481
NCT05759481CompletedPhase 2

Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Milton S. Hershey Medical Center2 sites in 1 country65 target enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
65
Locations
2
Primary Endpoint
Nausea (urge to vomit) episodes

Study Overview

Brief Summary

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.

Detailed Description

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hybrid anesthesia (propofol + sevoflurane)

Active Comparator

Participants received general anesthesia maintained with a continuous low-dose propofol infusion combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered.

Intervention: Hybrid anesthesia (propofol + sevoflurane) (Drug)

Propofol only TIVA

Active Comparator

Participants received general anesthesia maintained with propofol-based total intravenous anesthesia (TIVA). Propofol infusion was titrated to maintain a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered

Intervention: Propofol only TIVA (Drug)

Outcomes

Primary Outcomes

Nausea (urge to vomit) episodes

Time Frame: 24 hours

Number of self-reported nausea episodes

Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes

Time Frame: 24 hours

Number of self-reported retching episodes

Vomiting (forceful expulsion of gastric contents) episodes

Time Frame: 24 hours

Number of self-reported vomiting episodes

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

  • Choice of antiemetic- Prochlorperazine(24 hours)
  • Number of times metoclopramide administered(24 hours)
  • Choice of antiemetic- Dexamethasone(24 hours)
  • Number of times dexamethasone administered(24 hours)
  • Choice of antiemetic- Ondansetron(24 hours)
  • Choice of antiemetic- Promethazine(24 hours)
  • Number of times promethazine administered(24 hours)
  • Number of times prochlorperazine administered(24 hours)
  • Number of times ondansetron administered(24 hours)
  • Choice of antiemetic- metoclopramide(24 hours)
  • Choice of antiemetic- Droperidol(24 hours)
  • Number of times droperidol administered(24 hours)
  • Choice of antiemetic- scopolamine(24 hours)
  • Number of times scopolamine administered(24 hours)
  • Choice of antiemetic-diphenhydramine(24 hours)
  • Number of times diphenhydramine administered(24 hours)
  • Episodes of Post Operative Nausea/Vomiting (PONV)(PACU)
  • Use of Antiemetics(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Revati Kanekar

Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Milton S. Hershey Medical Center

Study Sites (2)

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