Caffeine in the Prevention of Post-operative Nausea and Vomiting
- Registration Number
- NCT00130026
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
The objective of this study is to determine if caffeine 500 mg intravenously is efficacious when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.
- Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled study of caffeine, 500 mg, intravenously, in addition to standard anti-emetic prophylaxis, in the prevention of post-operative nausea and vomiting in patients undergoing ambulatory surgery under general anesthesia.
Consenting patients will be randomized to receive either a single dose of caffeine, 500 mg, or saline placebo, administered as a single IV dose approximately 15 minutes before emergence from anesthesia. All patients will receive our customary anti-emetic prophylaxis, determined by four major risk factors for PONV: female gender, nonsmoking status, history of PONV or motion sickness, and perioperative opioid use. Patients at low risk for PONV (no risk factors) will receive no prophylaxis; patients at moderate risk for PONV (1 or 2 risk factors) will receive dexamethasone 8 mg at induction plus dolasetron 12.5 mg approximately 15 min before the end of anesthesia; patients at high risk for PONV (3 or 4 risk factors) will receive the same treatment as those at moderate risk, plus additional prophylaxis at the discretion of the attending anesthesiologist (e.g., scopolamine patch, metoclopramide 10 mg IV, or other standard drugs).
Postoperatively, the presence of PONV will be recorded. If rescue medication is used, the amount and time of administration will be recorded. The length of stay in the PACU (Phase I and Phase II) will be recorded. Patients will be asked to report any headache, and to rate their nausea, pain, alertness, fatigue, and overall satisfaction in the PACU, and again by phone 24 hours postoperatively. Amount of pain medication utilized in the PACU will also be measured.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- Patient having ambulatory surgery
- Patient receiving general anesthesia
- Patient is not willing to sign informed consent
- Patient does not speak or understand sufficient English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I Caffeine Saline placebo
- Primary Outcome Measures
Name Time Method Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia 1-24 hours post-operatively
- Secondary Outcome Measures
Name Time Method Nausea during the first 24 hours following anesthesia 1-24 hours post-operatively Admissions 1-24 hours post-operatively Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) hours post-operatively Vomiting during the first 24 hours following anesthesia 1-24 hours post-operatively Incidence of headache 1-24 hours post-operatively Overall satisfaction 1-24 hours post-operatively Alertness 1-24 hours post-operatively Proportion of patients who use rescue medication during the first 24 hours following anesthesia 1-24 hours post-operatively Degree of fatigue 1-24 hours post-operatively Amount of pain medication required 1-24 hours post-operatively
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States