A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2010 | ||||
| Last Updated Date | January 8, 2013 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01123837 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting | ||||
| Official Title ICMJE | A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting | ||||
| 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." |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Postop Nausea and Vomiting | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01123837 | ||||
| Other Study ID Numbers ICMJE | 5100086 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Richard Applegate, Loma Linda University | ||||
| Study Sponsor ICMJE | Loma Linda University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Loma Linda University | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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