Clinical trial NCT05406245: The Effect of Stress on the Residual Gastric Volume
Official title: The Effect of Stress on the Residual Gastric Volume in Older Adults Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis Knee
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 53
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Level of stress hormone 1
timeFrame: After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes
measure: Level of stress hormone 2
timeFrame: After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes
Secondary outcomes:
measure: Gastric volume 1
timeFrame: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
measure: Gastric volume 2
timeFrame: Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
measure: Anxiety scale 1
timeFrame: First stage operation, one day before surgery/ an average of 30 minutes
measure: Anxiety scale 2
timeFrame: Second stage operation, one day before surgery/ an average of 30 minutes
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: