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Caffeine in the Prevention of Post-operative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

I

Arm Description

Saline placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nausea during the first 24 hours following anesthesia
Vomiting during the first 24 hours following anesthesia
Proportion of patients who use rescue medication during the first 24 hours following anesthesia
Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II)
Incidence of headache
Degree of fatigue
Overall satisfaction
Alertness
Admissions
Amount of pain medication required

Full Information

First Posted
August 11, 2005
Last Updated
February 3, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00130026
Brief Title
Caffeine in the Prevention of Post-operative Nausea and Vomiting
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Placebo Comparator
Arm Description
Saline placebo
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
500 mg IV
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Nausea during the first 24 hours following anesthesia
Time Frame
1-24 hours post-operatively
Title
Vomiting during the first 24 hours following anesthesia
Time Frame
1-24 hours post-operatively
Title
Proportion of patients who use rescue medication during the first 24 hours following anesthesia
Time Frame
1-24 hours post-operatively
Title
Post Anesthesia Care Unit (PACU) length of stay (Phase I, Phase II)
Time Frame
hours post-operatively
Title
Incidence of headache
Time Frame
1-24 hours post-operatively
Title
Degree of fatigue
Time Frame
1-24 hours post-operatively
Title
Overall satisfaction
Time Frame
1-24 hours post-operatively
Title
Alertness
Time Frame
1-24 hours post-operatively
Title
Admissions
Time Frame
1-24 hours post-operatively
Title
Amount of pain medication required
Time Frame
1-24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Steinbrook, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Caffeine in the Prevention of Post-operative Nausea and Vomiting

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