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.

Condition	Intervention
POSTOP NAUSEA VOMITING	Drug: Caffeine

Further Study Details: 

Primary Outcomes: Vomiting during the first 24 hours following anesthesia
Secondary Outcomes: Vomiting during the 0-2 and 0-6 hour intervals following anesthesia; Nausea during the 0-2 hour, 0-6 hour, and 0-24 hour intervals following anesthesia; Complete response (no moderate/severe nausea, no vomiting, and no use of rescue medication) during the 0-2 hour, 0-6 hour, and 0-24 hour intervals following anesthesia.; Proportion of patients who use rescue medication during the 0-2 hour, 0-6 hour, and 0-24 hour interval following anesthesia.; PACU length of stay (Phase I, Phase II); Time to first vomiting episode; Time to first moderate/severe nausea episode; Time to first use of rescue medication; Incidence of headache; Degree of fatigue; Overall satisfaction; Alertness; Admissions; Amount of pain medication required
Expected Total Enrollment:  135

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 time of each vomiting episode will be recorded as will the time and intensity of each nausea episode. If rescue medication is used, the amount, the time of administration as well as the time to resolution of PONV symptoms 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, and fatigue in the PACU, and again by phone 24 hours postoperatively. Amount of pain medication utilized in the PACU will also be measured. Patients also will be asked to rate their overall satisfaction in the 24 hours postoperative phone interview.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00130026

Richard A Steinbrook, MD      6176673112 

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting

Study chairs or principal investigators

Richard A Steinbrook, MD,  Principal Investigator,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  2004P-000210
Last Updated:  August 12, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00130026
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23