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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Applegate, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01123837
First received: May 12, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

"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."


Condition Intervention
Postoperative Nausea and Vomiting
Other: Intravenous fluid
Other: D5LR or lactated ringers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 202
Study Start Date: April 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 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.
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123837

Locations
United States, California
Loma Linda University Medical Center Heart and Surgical Hospital
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Richard L Applegate, M.D. Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Richard Applegate, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01123837     History of Changes
Other Study ID Numbers: 5100086
Study First Received: May 12, 2010
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014