Clinical trial NCT00130026: Caffeine in the Prevention of Post-operative Nausea and Vomiting
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Study of Caffeine in the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Ambulatory Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2005-08-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia
timeFrame: 1-24 hours post-operatively
Secondary outcomes:
measure: Nausea during the first 24 hours following anesthesia
timeFrame: 1-24 hours post-operatively
measure: Vomiting during the first 24 hours following anesthesia
timeFrame: 1-24 hours post-operatively
measure: Proportion of patients who use rescue medication during the first 24 hours following anesthesia
timeFrame: 1-24 hours post-operatively
measure: Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II)
timeFrame: hours post-operatively
measure: Incidence of headache
timeFrame: 1-24 hours post-operatively
measure: Degree of fatigue
timeFrame: 1-24 hours post-operatively
measure: Overall satisfaction
timeFrame: 1-24 hours post-operatively
measure: Alertness
timeFrame: 1-24 hours post-operatively
measure: Admissions
timeFrame: 1-24 hours post-operatively
measure: Amount of pain medication required
timeFrame: 1-24 hours post-operatively
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Richard A Steinbrook, MD
role: PRINCIPAL_INVESTIGATOR
References: