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

Nausea and Vomiting, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301404
• Other study ID #: 763/2553(EC2)
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2011
• Last updated: July 18, 2013
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of hyperglycemia during perioperative period	Regarding to the perioperative stress and carbohydrate drinking, we also measure blood sugar before and postoperation and compare their values between groups	24 hours	Yes