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

Primary Purpose

Spinal Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oral carbohydrate beverage
control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Disease focused on measuring postoperative nausea and vomiting, oral carbohydrate beverage

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oral carbohydrate beverage group

control group

Arm Description

Outcomes

Primary Outcome Measures

incidence of nausea and vomiting

Secondary Outcome Measures

severity of nausea
11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)

Full Information

First Posted
June 20, 2016
Last Updated
June 19, 2018
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02809950
Brief Title
Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Disease
Keywords
postoperative nausea and vomiting, oral carbohydrate beverage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral carbohydrate beverage group
Arm Type
Experimental
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
oral carbohydrate beverage
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
NPO from midnight of the day before surgery
Primary Outcome Measure Information:
Title
incidence of nausea and vomiting
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
severity of nausea
Description
11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Sun Cho, MD
Phone
82-2-2227-0396
Email
chjs0214@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Sun Cho, MD
Phone
82-2-2227-0396
Email
chjs0214@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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