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A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravenous fluid
D5LR or lactated ringers
Sponsored by
Loma Linda University
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 - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. ASA I or II
  2. female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital

Exclusion Criteria:

  1. age <18 or >65;
  2. severe hypertension,diabetes mellitus, significant hepatic or renal disease
  3. excessive blood loss
  4. sustained (>10 min)>20% from baseline drop in BP after treatment
  5. inability to follow protocol
  6. refusal to sign consent

Sites / Locations

  • Loma Linda University Medical Center Heart and Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

D5LR

lactated ringers

Arm Description

In the treatment group, a 250cc bolus over 2 hrs of D5LR will be initiated prior to the end of surgery and continued in PACU.Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning

In the control group, a 250cc bolus over 2 hrs of LR will be initiated prior to the end of surgery and continued in PACU. Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning.

Outcomes

Primary Outcome Measures

A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting
The primary outcome measures will be the severity and incidence of PONV along with the type and number of rescue medications given at 0,30,60, and 120 minutes PACU time and the next morning.

Secondary Outcome Measures

A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting
Secondary endpoints recorded will be length of surgery, history of PONV, amount of pain medicine administered, blood loss, drop in BP > 20%, unplanned hospital admission for PONV, and time till ready for discharge from PACU.

Full Information

First Posted
May 12, 2010
Last Updated
January 20, 2014
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT01123837
Brief Title
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
Official Title
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
"The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."

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 ProviderInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D5LR
Arm Type
Active Comparator
Arm Description
In the treatment group, a 250cc bolus over 2 hrs of D5LR will be initiated prior to the end of surgery and continued in PACU.Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning
Arm Title
lactated ringers
Arm Type
Active Comparator
Arm Description
In the control group, a 250cc bolus over 2 hrs of LR will be initiated prior to the end of surgery and continued in PACU. Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning.
Intervention Type
Other
Intervention Name(s)
Intravenous fluid
Intervention Description
The treatment group will receive a 250cc bolus over 2 hrs of D5LR prior to the end of surgery and continued in the PACU. Blood glucose will be checked 3 different times using an Accu-chek monitor along with the type and number of rescue medications given at 30, 60, and 120 minutes after anesthesia and the post-op morning. The control group will receive a 250cc bolus over 2 hours of LR. Blood glucose will be monitored 3 times along with the type and how much of rescue medications are given at 30, 60 and 120 minutes post-op and the morning after surgery.
Intervention Type
Other
Intervention Name(s)
D5LR or lactated ringers
Intervention Description
The purpose of the study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood sugar level. The reason for this study is that IV dextrose may decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction.
Primary Outcome Measure Information:
Title
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting
Description
The primary outcome measures will be the severity and incidence of PONV along with the type and number of rescue medications given at 0,30,60, and 120 minutes PACU time and the next morning.
Time Frame
approximately 24 hours
Secondary Outcome Measure Information:
Title
A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting
Description
Secondary endpoints recorded will be length of surgery, history of PONV, amount of pain medicine administered, blood loss, drop in BP > 20%, unplanned hospital admission for PONV, and time till ready for discharge from PACU.
Time Frame
approximately 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I or II female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital Exclusion Criteria: age <18 or >65; severe hypertension,diabetes mellitus, significant hepatic or renal disease excessive blood loss sustained (>10 min)>20% from baseline drop in BP after treatment inability to follow protocol refusal to sign consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Applegate, M.D.
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center Heart and Surgical Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

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A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

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