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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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Yonsei University

Status and phase

Unknown
Phase 4

Conditions

Spinal Disease

Treatments

Other: oral carbohydrate beverage
Other: control group

Study type

Interventional

Funder types

Other

Identifiers

NCT02809950
4-2015-0984

Details and patient eligibility

About

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.

Enrollment

288 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

288 participants in 2 patient groups, including a placebo group

oral carbohydrate beverage group
Experimental group
Treatment:
Other: oral carbohydrate beverage
control group
Placebo Comparator group
Treatment:
Other: control group

Trial contacts and locations

1

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Central trial contact

Jin Sun Cho, MD

Data sourced from clinicaltrials.gov

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