Caffeine in the Prevention of Post-Operative Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00130026
First received: August 11, 2005
Last updated: December 26, 2007
Last verified: September 2006
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
Placebo Comparator: I
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Richard A. Steinbrook, MD, principal investigator, BIDMC
ClinicalTrials.gov Identifier: NCT00130026     History of Changes
Other Study ID Numbers: 2004P-000210
Study First Received: August 11, 2005
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 01, 2014