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Completed

NCT Number: NCT04206189

Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients

Postoperative cognitive dysfunction (POCD) is more common in older patients, and increased insulin resistance is an important factor for POCD. Fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. However, prolonged fasting increases insulin resistance. Recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. Therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. Fifty patients (age>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 h before surgery according to standard protocol.

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Key information

Conditions

Old Age

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing arthroplasty
  • age>65 years

Exclusion criteria

  • The subject is a foreigner or illiterate
  • Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
  • Patients with chronic renal disease or severe cardiovascular disease
  • HbA1c >69 mmol/mol or BMI >30 kg/m2
  • A duration of ≥5 h between consumption of CHO and initiation of surgery.

Treatment and study plan

carbohydrate group - carbohydrate (400ml)

Dietary Supplement

Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery. In contrast, patients in the control group are fasted water 2 hours before surgery according to the standard protocol.

Primary outcomes

  1. Insulin resistance

    Time frame: Before anesthesia

    Insulin resistance index = glucose x insulin/22.5

  2. Insulin resistance

    Time frame: 1 hour after surgery

    Insulin resistance index = glucose x insulin/22.5

Secondary outcomes

  1. glycemic variability

    Time frame: Before anesthesia

    Coefficient of glucose variability =SD/mean x 100 (%)

  2. glycemic variability

    Time frame: 5 minutes after anesthesia

    Coefficient of glucose variability =SD/mean x 100 (%)

  3. glycemic variability

    Time frame: 1 hour after surgery

    Coefficient of glucose variability =SD/mean x 100 (%)

  4. glycemic variability

    Time frame: 10 minutes after admission of recovery room

    Coefficient of glucose variability =SD/mean x 100 (%)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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