Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery

Spinal Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02809950
• Other study ID #: 4-2015-0984
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: Jin Sun Cho, MD
• Phone: 82-2-2227-0396
• Email: chjs0214[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• female patient between 20 and 65 of age with ASA physical status ?-?

• patient scheduled for elective spine surgery

• no smoking history

Exclusion Criteria:

• hepatorenal disease

• BMI > 35 kg/m2

• gastrointestinal disease

• vomiting within 24h

• administration of antiemetics or opioids within 24 h prior to surgery

• pregnant

• problem with communication

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Spinal Disease
• Spinal Diseases

Intervention

Other:
• oral carbohydrate beverage
oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively
• control group
NPO from midnight of the day before surgery

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of nausea and vomiting		48 hours
Secondary	severity of nausea	11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)	48 hours