Inflammatory Response to Opioid Versus Opioid Free Anesthesia

NCT04854252 | Completed DMC

• 1 other identifier: 09042021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthetic agents, including opioids can modulate the altered immune function in patients with obesity through mechanisms that involve the expression and release of cytokines. For this reason, anesthetic care in patients with obesity remains controversial. Therefore, the aim of the study was to compare the effect of opioid-containing anesthesia vs opioid-free anesthesia using the Cortínez-Sepúlveda model on serum levels of IL-6, IL-1β and TNF-α before and after surgery in obese patients undergoing bypass surgery. Methods: A randomized cross-sectional study of 40 unrelated obese adults was performed in the Anesthesiology and Bariatric Surgery Service at the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca". Before undergoing laparoscopic Roux-en-Y gastric bypass, patients were randomly assigned to two anesthesia groups: opiod-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl. To characterize the disposition of intravenous propofol for the target-controlled infusion technique in obese patients, the Cortínez-Sepúlveda pharmacokinetic model was used. Body mass was determined to the nearest 0.05kg using a balance scale (Seca 703; Seca, Hamburg, Germany). Blood samples were taken before and immediately after surgery and cytokine serum levels were determined with ELISA kits. Statistical analyses were performed using the IBM Statistical Package for the Social Sciences software package version 20.0 (IBM Corp., Armonk, NY, USA).

Conditions

Morbid Obesity; Opioid Use; Fentanyl Adverse Reaction; Cytokine Storm

Keywords

Morbid obesity; Gastric bypass; Opioid containing anesthesia; Opioid free anesthesia; Cytokines

Outcome Measures

Primary Outcomes (1)

• Differences in the inflammatory response determined by serum cytokine levels when using opioid-containing anesthesia or opioid-free anesthesia in patients undergoing bypass surgery

  Cytokine serum levels were measured with an enzyme-linked immunosorbent (ELISA) assay. LEGEND MAX™ Human IL-1β (cat # 437007), LEGEND MAX™ Human IL-6 (cat # 430507) and LEGEND MAX™ Human TNF-α (cat # 430207) ELISA kits

  30 minutes before the anesthesia administration and 5 minutes before extubation

Study Arms (1)

Inflammatory response to opioid vs opioid free anesthesia

EXPERIMENTAL

Patients were randomly assigned to two anesthesia groups: opioid-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl.

Drug: Fentanyl

Interventions

Fentanyl DRUG

TIVA opioid-containing anesthesia: fentanyl in a bolus dose of l3 mcg/kg (corrected weight) TIVA opioid-free anesthesia: dexmedetomidine 1-1.5 mcg/kg (corrected weight) for 40 minutes

Inflammatory response to opioid vs opioid free anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Who were scheduled for bypass surgery at the Service of Anesthesiology and Bariatric Surgery of the Civil Hospital of Guadalajara "Dr. Juan I Menchaca", Jalisco, Mexico, were recruited.

You may not qualify if:

• Patients with a history of ischemic heart disease, history of drug abuse, and with any known allergy to any of the drugs used during anesthesia. Elimination criteria were: patients who withdrew their consent or with insufficient and poor quality blood samples (coagulated) or other reasons that did not allow sample processing.

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Erika Martínez-López

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• Campos-Perez W, Ramirez-Plascencia L, Perez-Robles M, Rivera-Valdes JJ, Sanchez-Munoz P, Perez-Vargas L, Gonzalez-Landeros D, Cuevas JHM, Martinez-Lopez E. A comparison of opioid-containing anesthesia versus opioid-free anesthesia using the Cortinez-Sepulveda model on differential cytokine responses in obese patients undergoing gastric bypass surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Sep 16;22(1):294. doi: 10.1186/s12871-022-01838-8.

  PMID: 36114460 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Cytokine Release Syndrome

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Patients were randomly assigned to two anesthesia groups: opioid-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl.

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 22, 2021
• Study Start: November 12, 2020
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)