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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01123837
First received: May 12, 2010
Last updated: January 8, 2013
Last verified: January 2013

May 12, 2010
January 8, 2013
April 2010
April 2013   (final data collection date for primary outcome measure)
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting [ Time Frame: approximately 24 hours ] [ Designated as safety issue: No ]
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.
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting [ Time Frame: approximately 24 hours ] [ Designated as safety issue: No ]
The primary outcome measures will be blood glucose levels associated with PONV, the severity and incidence of PONV along with the type and number of rescue medicines.
Complete list of historical versions of study NCT01123837 on ClinicalTrials.gov Archive Site
A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting [ Time Frame: approximately 24 hours ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

"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."

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Postop Nausea and Vomiting
  • Other: Intravenous fluid

    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.

  • Other: D5LR or lactated ringers

    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.

  • Active Comparator: D5LR
    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
    Interventions:
    • Other: Intravenous fluid
    • Other: D5LR or lactated ringers
  • Active Comparator: lactated ringers
    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.
    Interventions:
    • Other: Intravenous fluid
    • Other: D5LR or lactated ringers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01123837
5100086
Yes
Richard Applegate, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Parul Patel, M.D. Loma Linda University Medical Center
Loma Linda University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP