Postoperative Nausea and Vomiting
Conditions
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.
Interventions
DRUGCaffeine
500 mg IV
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient having ambulatory surgery * Patient receiving general anesthesia
Exclusion criteria
* Patient is not willing to sign informed consent * Patient does not speak or understand sufficient English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia | 1-24 hours post-operatively |
Secondary
| Measure | Time frame |
|---|---|
| Vomiting during the first 24 hours following anesthesia | 1-24 hours post-operatively |
| Proportion of patients who use rescue medication during the first 24 hours following anesthesia | 1-24 hours post-operatively |
| Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) | hours post-operatively |
| Incidence of headache | 1-24 hours post-operatively |
| Nausea during the first 24 hours following anesthesia | 1-24 hours post-operatively |
| Overall satisfaction | 1-24 hours post-operatively |
| Alertness | 1-24 hours post-operatively |
| Admissions | 1-24 hours post-operatively |
| Amount of pain medication required | 1-24 hours post-operatively |
| Degree of fatigue | 1-24 hours post-operatively |
Countries
United States
Outcome results
None listed