The Effect of Stress on the Residual Gastric Volume

NCT05406245 | Unknown

• 1 other identifier: B-2206-761-301
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested. In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.

Conditions

Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Level of stress hormone 1

  Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia

  After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes

• Level of stress hormone 2

  Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia

  After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes

Secondary Outcomes (4)

• Gastric volume 1

  First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes

• Gastric volume 2

  Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes

• Anxiety scale 1

  First stage operation, one day before surgery/ an average of 30 minutes

• Anxiety scale 2

  Second stage operation, one day before surgery/ an average of 30 minutes

Study Arms (1)

Group C

Patients drank carbohydrate fluid 2 hours prior to surgery.

Dietary Supplement: Carbohydrate drinking

Interventions

Carbohydrate drinking DIETARY_SUPPLEMENT

Administration of carbohydrate fluid

Group C

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be patients who are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.

You may qualify if:

• Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
• American Society of Anesthesiologists physical status classification 1, 2, and 3
• Body mass index \< 35 kg/cm2
• Patients administered carbohydrate-containing fluid 2 hours prior to surgery

You may not qualify if:

• Previous surgery of the upper gastrointestinal tract
• Achalasia
• Diabetes

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Study Officials

• Hyo-Seok Na, MD., PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Jung Shin, MD., PhD.

CONTACT

82317877508; hjshin.anesth@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: July 1, 2022
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)