Caffeine in the Prevention of Post-operative Nausea and Vomiting
关键词
抽象
描述
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.
日期
| 最后验证: | 01/31/2017 |
| 首次提交: | 08/10/2005 |
| 提交的预估入学人数: | 08/11/2005 |
| 首次发布: | 08/14/2005 |
| 上次提交的更新: | 02/02/2017 |
| 最近更新发布: | 02/06/2017 |
| 实际学习开始日期: | 02/28/2005 |
| 预计主要完成日期: | 09/30/2005 |
| 预计完成日期: | 09/30/2005 |
状况或疾病
干预/治疗
Drug: I
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: I Saline placebo | Drug: I 500 mg IV |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia [1-24 hours post-operatively]
次要成果指标
1. Nausea during the first 24 hours following anesthesia [1-24 hours post-operatively]
2. Vomiting during the first 24 hours following anesthesia [1-24 hours post-operatively]
3. Proportion of patients who use rescue medication during the first 24 hours following anesthesia [1-24 hours post-operatively]
4. Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) [hours post-operatively]
5. Incidence of headache [1-24 hours post-operatively]
6. Degree of fatigue [1-24 hours post-operatively]
7. Overall satisfaction [1-24 hours post-operatively]
8. Alertness [1-24 hours post-operatively]
9. Admissions [1-24 hours post-operatively]
10. Amount of pain medication required [1-24 hours post-operatively]
