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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1091220090
Enrollment
50
Registered
2012-06-25
Start date
2011-01-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the patients undergoing elective gastrectomy

Interventions

Intervention type:DRUG Name of intervention: high dose remifentanil Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per

Sponsors

School of Nutrition & Dietetics, Kanagawa University of Human Services
Lead Sponsor
Department of Anesthesiology, Kanagawa Cancer Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
Homeostasis model assessment as an index of insulin resistance (HOMA-IR) 3-methylhistidine/creatinine (3-MH/Cr)

Secondary

MeasureTime frame
intraoperative stress hormones(ACTH,cortisol,adrenarin etc.) , insulin, and blood glucose

Countries

Japan

Contacts

Public ContactHIDEKI TANIGUCHI

School of Nutrition & Dietetics, Kanagawa University of Human Services

hstani@aol.com+81-46-828-2660

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026