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Caffeine in the Prevention of Post-operative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT00130026
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Richard A. Steinbrook, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Caffeine Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: I
Saline placebo
 Drug: Caffeine
500 mg IV


Outcome Measures
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Primary Outcome Measures :
  1. Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]

Secondary Outcome Measures :
  1. Nausea during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
  2. Vomiting during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
  3. Proportion of patients who use rescue medication during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ]
  4. Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) [ Time Frame: hours post-operatively ]
  5. Incidence of headache [ Time Frame: 1-24 hours post-operatively ]
  6. Degree of fatigue [ Time Frame: 1-24 hours post-operatively ]
  7. Overall satisfaction [ Time Frame: 1-24 hours post-operatively ]
  8. Alertness [ Time Frame: 1-24 hours post-operatively ]
  9. Admissions [ Time Frame: 1-24 hours post-operatively ]
  10. Amount of pain medication required [ Time Frame: 1-24 hours post-operatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Richard A Steinbrook, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Richard A. Steinbrook, Associate Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00130026    
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
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