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

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Other: Intravenous fluid; Other: D5LR or lactated ringers

• Registration Number: NCT01123837
• Lead Sponsor: Loma Linda University

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."

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D5LR	Intravenous fluid	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
D5LR	D5LR or lactated ringers	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
lactated ringers	Intravenous fluid	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.
lactated ringers	D5LR or 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.

Primary Outcome Measures

Name	Time	Method
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting	approximately 24 hours	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

Name	Time	Method
A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting	approximately 24 hours	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center Heart and Surgical Hospital; 🇺🇸 Loma Linda, California, United States