Caffeine in the Prevention of Post-operative Nausea and Vomiting
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| ClinicalTrials.gov Identifier: NCT00130026 |
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Recruitment Status :
Completed
First Posted : August 15, 2005
Last Update Posted : February 7, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Nausea and Vomiting | Drug: Caffeine | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 135 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 Start Date : | March 2005 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: I
Saline placebo
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Drug: Caffeine
500 mg IV |
- Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
- Nausea during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
- Vomiting during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
- Proportion of patients who use rescue medication during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
- Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) [ Time Frame: hours post-operatively ]
- Incidence of headache [ Time Frame: 1-24 hours post-operatively ]
- Degree of fatigue [ Time Frame: 1-24 hours post-operatively ]
- Overall satisfaction [ Time Frame: 1-24 hours post-operatively ]
- Alertness [ Time Frame: 1-24 hours post-operatively ]
- Admissions [ Time Frame: 1-24 hours post-operatively ]
- Amount of pain medication required [ Time Frame: 1-24 hours post-operatively ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130026
| 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: | Richard A. Steinbrook, Associate Professor of Anaesthesia, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00130026 History of Changes |
| Other Study ID Numbers: |
2004P000210 |
| First Posted: | August 15, 2005 Key Record Dates |
| Last Update Posted: | February 7, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
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Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Caffeine Central Nervous System Stimulants |
Physiological Effects of Drugs Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |