NCT00130026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

August 11, 2005

Last Update Submit

February 3, 2017

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Complete response (no PONV and no use of rescue medication) during the first 24 hours following anesthesia

    1-24 hours post-operatively

Secondary Outcomes (10)

  • Nausea during the first 24 hours following anesthesia

    1-24 hours post-operatively

  • Vomiting during the first 24 hours following anesthesia

    1-24 hours post-operatively

  • Proportion of patients who use rescue medication during the first 24 hours following anesthesia

    1-24 hours post-operatively

  • Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II)

    hours post-operatively

  • Incidence of headache

    1-24 hours post-operatively

  • +5 more secondary outcomes

Study Arms (1)

I

PLACEBO COMPARATOR

Saline placebo

Drug: Caffeine

Interventions

CaffeineDRUG

500 mg IV

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient having ambulatory surgery
  • Patient receiving general anesthesia

You may not qualify if:

  • Patient is not willing to sign informed consent
  • Patient does not speak or understand sufficient English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Richard A Steinbrook, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesia

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 15, 2005

Study Start

March 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)