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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
History of Changes
  Purpose

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 Intervention Phase
Nausea and Vomiting, Postoperative
 Dietary Supplement: 10% carbohydrate drink
Other: No intervention
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: nothing
No intervention
 Other: No intervention
No intervention
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)

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301404

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

No publications provided

Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01301404     History of Changes
Other Study ID Numbers: 763/2553(EC2)
Study First Received: February 20, 2011
Last Updated: June 26, 2012
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013