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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00130026 |
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 |
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Postoperative Nausea and Vomiting |
Drug: Caffeine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 135 |
Study Start Date: | March 2005 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Placebo Comparator
Saline placebo
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Drug: Caffeine
500 mg IV
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Richard A Steinbrook, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | BIDMC ( Richard A. Steinbrook, MD, principal investigator ) |
Study ID Numbers: | 2004P-000210 |
Study First Received: | August 11, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00130026 |
Health Authority: | United States: Institutional Review Board |
Caffeine citrate Signs and Symptoms Postoperative Nausea and Vomiting Vomiting Postoperative Complications |
Signs and Symptoms, Digestive Citric Acid Caffeine Nausea |
Phosphodiesterase Inhibitors Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Stimulants Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |