Clinical trial NCT04206189: Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Official title: Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Insulin resistance
timeFrame: Before anesthesia
measure: Insulin resistance
timeFrame: 1 hour after surgery
Secondary outcomes:
measure: glycemic variability
timeFrame: Before anesthesia
measure: glycemic variability
timeFrame: 5 minutes after anesthesia
measure: glycemic variability
timeFrame: 1 hour after surgery
measure: glycemic variability
timeFrame: 10 minutes after admission of recovery room
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.