Inflammatory Response to Opioid Versus Opioid Free Anesthesia

• ClinicalTrials.gov Identifier: NCT04854252
• Recruitment Status: Completed
• First Posted: April 22, 2021
• Last Update Posted: April 22, 2021
• Sponsor: University of Guadalajara
• Information provided by (Responsible Party): ERIKA MARTINEZ-LOPEZ, University of Guadalajara

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Morbid Obesity; Opioid Use; Fentanyl Adverse Reaction; Cytokine Storm	Drug: Fentanyl	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Comparison of Opioid-containing Anesthesia Versus Opioid-free Anesthesia Using the Cortínez-Sepúlveda Model on Differential Cytokine Responses in Patients Undergoing Gastric Bypass Surgery
• Actual Study Start Date: November 12, 2020
• Actual Primary Completion Date: March 29, 2021
• Actual Study Completion Date: March 29, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Inflammatory response to opioid vs opioid free anesthesia; 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; 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

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 30 minutes before the anesthesia administration and 5 minutes before extubation ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Mexico

Erika Martínez-López

Guadalajara, Jalisco, Mexico, 44340

Sponsors and Collaborators

University of Guadalajara

More Information

• Responsible Party: ERIKA MARTINEZ-LOPEZ, PhD, University of Guadalajara
• ClinicalTrials.gov Identifier: NCT04854252
• Other Study ID Numbers: 09042021
• First Posted: April 22, 2021
• Last Update Posted: April 22, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by ERIKA MARTINEZ-LOPEZ, University of Guadalajara:

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

Additional relevant MeSH terms:

Obesity, Morbid; Cytokine Release Syndrome; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock; Fentanyl; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics