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

NCT01301404 | Completed Phase 1

• 1 other identifier: 763/2553(EC2)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting, Postoperative

Keywords

Postoperative nausea and vomiting (PONV); Spinal morphine; Total knee replacement (TKR); blood sugar; carbohydrate drink

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative nausea and vomiting after TKR

  Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group

  24 hours

Secondary Outcomes (1)

• Incidence of hyperglycemia during perioperative period

  24 hours

Study Arms (2)

control

NO INTERVENTION

patient receive nothing

carbohydrate drink

EXPERIMENTAL

10%carbohydrate drink

Dietary Supplement: 10% carbohydrate drink

Interventions

10% carbohydrate drink DIETARY_SUPPLEMENT

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.

Also known as: Green mate (orange favor)

carbohydrate drink

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• Manee Raksakietisak, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 20, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 19, 2013

Record last verified: 2012-06

Locations

TH (1)