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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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ClinicalTrials.gov Identifier: NCT02809950
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Spinal Disease Other: oral carbohydrate beverage Other: control group Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oral carbohydrate beverage group 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

Placebo Comparator: control group Other: control group
NPO from midnight of the day before surgery




Primary Outcome Measures :
  1. incidence of nausea and vomiting [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. severity of nausea [ Time Frame: 48 hours ]
    11-point numerical rating scale (0: no nausea ~10: worst imaginable nausea)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809950


Contacts
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Contact: Jin Sun Cho, MD 82-2-2227-0396 chjs0214@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jin Sun Cho, MD    82-2-2227-0396    chjs0214@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02809950     History of Changes
Other Study ID Numbers: 4-2015-0984
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yonsei University:
postoperative nausea and vomiting, oral carbohydrate beverage

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Spinal Diseases
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
Bone Diseases
Musculoskeletal Diseases