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

NCT ID: NCT04206189

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcomes assessor are blinded to group assignment.

Study Groups

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Carbohydrate group

Group Type ACTIVE_COMPARATOR

carbohydrate group - carbohydrate (400ml)

Intervention Type 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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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carbohydrate group - carbohydrate (400ml)

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing arthroplasty
2. age\>65 years

Exclusion Criteria

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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He X, Long G, Quan C, Zhang B, Chen J, Ouyang W. Insulin Resistance Predicts Postoperative Cognitive Dysfunction in Elderly Gastrointestinal Patients. Front Aging Neurosci. 2019 Aug 8;11:197. doi: 10.3389/fnagi.2019.00197. eCollection 2019.

Reference Type BACKGROUND
PMID: 31440156 (View on PubMed)

Tang N, Jiang R, Wang X, Wen J, Liu L, Wu J, Zhang C. Insulin resistance plays a potential role in postoperative cognitive dysfunction in patients following cardiac valve surgery. Brain Res. 2017 Feb 15;1657:377-382. doi: 10.1016/j.brainres.2016.12.027. Epub 2016 Dec 31.

Reference Type BACKGROUND
PMID: 28048971 (View on PubMed)

Choi YS, Cho BW, Kim HJ, Lee YS, Park KK, Lee B. Effect of Preoperative Oral Carbohydrates on Insulin Resistance in Older Adults Who Underwent Total Hip or Knee Arthroplasty: A Prospective Randomized Trial. J Am Acad Orthop Surg. 2022 Oct 15;30(20):971-978. doi: 10.5435/JAAOS-D-21-00656. Epub 2022 May 13.

Reference Type DERIVED
PMID: 35576534 (View on PubMed)

Other Identifiers

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4-2019-1014

Identifier Type: -

Identifier Source: org_study_id

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