10% Carbohydrate Drink for Preventing Post-operative Nausea and Vomiting (PONV) After Spinal Morphine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University
ClinicalTrials.gov Identifier:
NCT01301404
First received: February 20, 2011
Last updated: June 26, 2012
Last verified: June 2012

February 20, 2011
June 26, 2012
February 2011
June 2012   (final data collection date for primary outcome measure)
The incidence of postoperative nausea and vomiting after TKR [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group
Same as current
Complete list of historical versions of study NCT01301404 on ClinicalTrials.gov Archive Site
Incidence of hyperglycemia during perioperative period [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Regarding to the perioperative stress and carbohydrate drinking, we also measure blood sugar before and postoperation and compare their values between groups
Incidence of hyperglycemia during perioperative period [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Regarding to the perioperative stress and carbohydrate drinking, we also measure blood sugar before and postoperation and compare their values between groups
Not Provided
Not Provided
 
10% Carbohydrate Drink for Preventing Post-operative Nausea and Vomiting (PONV) After Spinal Morphine
Oral Rehydration Therapy With 10% Carbohydrate Drink for Preventing Postoperative Nausea and Vomiting (PONV) After Low Dose of Spinal Morphine in Patients Undergoing Total Knee Replacement

PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal approach, combining several means to minimize PONV, has found wide acceptance as a standard of care. In our hospital, most of the patients are supposed to fast after midnight The oral rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is not investigated yet. The aim of this study is to investigate the effect of preoperative oral rehydration therapy on the incidence of PONV.

We enroll patients who are undergoing TKR under spinal anesthesia with 0.5% heavy bupivacaine 10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25% bupivacaine 20 ml.

The enrolled patients will fast after midnight and in the morning they are allowed to drink 10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10% carbohydrate drink is drunk between evening and midnight and extra water if needed in the study group. In the control group, the patients are allowed to drink until midnight. Total of water consumption between 18.00-24.00 will be recorded in both groups. In the morning, the study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. The premedications should not include sedation or GI mobility drugs. Before starting anesthesia, the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh their feeling from 0-10.

The surgery and pain therapy will be tha same in both groups and the PONV (incidence, severity and rescue therapy) at recovery room and 24 hours postoperative period will be recorded.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Nausea and Vomiting, Postoperative
  • Dietary Supplement: 10% carbohydrate drink
    In the study group, 10% carbohydrate drink 400 ml will be given between 18-24 hr the night before surgery and another 400 ml will be drunk at 6-7 hr in the morning of surgery.
    Other Name: Green mate (orange favor)
  • Other: No intervention
    No intervention
  • No Intervention: nothing
    No intervention
    Intervention: Other: No intervention
  • Experimental: carbohydrate drink
    10%carbohydrate drink
    Intervention: Dietary Supplement: 10% carbohydrate drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are under going unilateral TKR, with ASA I-III who scheduled started in the morning list (before noon)

Exclusion Criteria:

  • Diabetes
  • History of motion sickness
  • Chronic kidney disease (CKD, creatinine > 2 mg/dl)
  • Hiatus hernia or gastro esophageal reflux
  • Patients receiving drugs that might affect GI motility such as opioids
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01301404
763/2553(EC2)
No
Manee Raksakietisak, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Manee Raksakietisak, MD Mahidol University
Mahidol University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP