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Completed

NCT Number: NCT00130026

Caffeine in the Prevention of Post-operative Nausea and Vomiting

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

500 mg IV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 15, 2005
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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