Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
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)
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
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
Revati Kanekar
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Milton S. Hershey Medical Center