Randomized controlled study of the effect of intraoperative use of high-dose remifentanil on postoperative insulin resistance and muscle protein catabolism

Phase 4

Recruiting

• Conditions: the patients undergoing elective gastrectomy

• Registration Number: JPRN-jRCT1091220090
• Lead Sponsor: School of Nutrition & Dietetics, Kanagawa University of Human Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Subjects were patients scheduled to undergo laparotomic or laparoscopic elective gastrectomy (total gastrectomy, distal gastrectomy, or fundectomy). They met all the following eligibility criteria, and none of the exclusion criteria described below applied to any of the subjects. Eligibility criteria were as follows: Age ?45 and <75 years, American Society of Anesthesiologists physical status (ASA-PS) grade I or II, and informed consent obtained from the patient in writing prior to enrollment.

Exclusion Criteria

Exclusion criteria were as follows: advanced cancer-related muscle protein catabolism prior to surgery(serum albumin 3.0 g/dL, total lymphocyte count in peripheral blood 1200 per field of vision, subjective global assessment of nutritional status grade C, or CRP 1.0 mg/dL in the absence of obvious infection), history of ischemic heart disease or cerebrovascular disturbance, evident renal dysfunction (creatinine clearance 20 mL/min, or patients on dialysis), evident electrolyte disturbance (values outside normal limits for our facility), steroid administration, morbid obesity (body mass index, BMI over 35), and hemoglobin A1c (HbA1C) >6.5% (irrespective of type of treatment or complications of diabetes). Cases where 1) the intraoperative blood loss exceeded 500 mL, 2) the surgical procedure was changed intraoperatively, 3) insulin or glucose administration was required during surgery for the purpose of blood glucose control, or 4) remifentanil dosage departed from the prescribed dose, were treated as having discontinued or dropped out of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Homeostasis model assessment as an index of insulin resistance (HOMA-IR) <br>3-methylhistidine/creatinine (3-MH/Cr)

Secondary Outcome Measures

Name	Time	Method
intraoperative stress hormones(ACTH,cortisol,adrenarin etc.)<br>, insulin, and blood glucose