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

NCT01123837 | Completed DMC

• 1 other identifier: 5100086
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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."

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting

  approximately 24 hours

Study Arms (2)

D5LR

ACTIVE COMPARATOR

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; Other: D5LR or lactated ringers

lactated ringers

ACTIVE COMPARATOR

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; Other: D5LR or lactated ringers

Interventions

Intravenous fluid OTHER

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; lactated ringers

D5LR or lactated ringers OTHER

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.

D5LR; lactated ringers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center Heart and Surgical Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Richard L Applegate, M.D.

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

US (1)