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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01301404
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : July 19, 2013
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting, Postoperative Dietary Supplement: 10% carbohydrate drink Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: control
patient receive nothing
Experimental: carbohydrate drink
10%carbohydrate drink
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)

Primary Outcome Measures :
  1. The incidence of postoperative nausea and vomiting after TKR [ Time Frame: 24 hours ]
    Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group

Secondary Outcome Measures :
  1. Incidence of hyperglycemia during perioperative period [ Time Frame: 24 hours ]
    Regarding to the perioperative stress and carbohydrate drinking, we also measure blood sugar before and postoperation and compare their values between groups

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01301404

Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Manee Raksakietisak, MD Mahidol University

Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University Identifier: NCT01301404     History of Changes
Other Study ID Numbers: 763/2553(EC2)
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: June 2012

Keywords provided by Manee Raksakietisak, Mahidol University:
Postoperative nausea and vomiting (PONV)
Spinal morphine
Total knee replacement (TKR)
blood sugar
carbohydrate drink

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents