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Caffeine in the Prevention of Post-Operative Nausea and Vomiting
This study has been completed.
Sponsored by: Beth Israel Deaconess Medical Center
Information provided by: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00130026
  Purpose

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
Postoperative Nausea and Vomiting
Drug: Caffeine

MedlinePlus related topics: Anesthesia Caffeine Nausea and Vomiting
Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate
U.S. FDA Resources
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

Further study details as provided by Beth Israel Deaconess Medical Center:

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

Secondary Outcome Measures:
  • Nausea during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Vomiting during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Proportion of patients who use rescue medication during the first 24 hours following anesthesia [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II) [ Time Frame: hours post-operatively ] [ Designated as safety issue: No ]
  • Incidence of headache [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Degree of fatigue [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Overall satisfaction [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Alertness [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Admissions [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]
  • Amount of pain medication required [ Time Frame: 1-24 hours post-operatively ] [ Designated as safety issue: No ]

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
I: Placebo Comparator
Saline placebo
Drug: Caffeine
500 mg IV

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130026

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Richard A Steinbrook, MD Beth Israel Deaconess Medical Center
  More Information

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

Study placed in the following topic categories:
Caffeine citrate
Signs and Symptoms
Postoperative Nausea and Vomiting
Vomiting
Postoperative Complications
Signs and Symptoms, Digestive
Citric Acid
Caffeine
Nausea

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009