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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123837
• Other study ID #: 5100086
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: January 20, 2014
• Start date: April 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center Heart and Surgical Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	approximately 24 hours	No
Secondary	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.	approximately 24 hours	No