Inflammatory Response to Opioid Versus Opioid Free Anesthesia

Opioid Use Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854252
• Other study ID #: 09042021
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: March 29, 2021

Study information

• Verified date: April 2021
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cytokine Storm
• Fentanyl Adverse Reaction
• Morbid Obesity
• Obesity, Morbid
• Opioid Use

Intervention

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

Locations

Country	Name	City	State
Mexico	Erika Martínez-López	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-1ß (cat # 437007), LEGEND MAX™ Human IL-6 (cat # 430507) and LEGEND MAX™ Human TNF-a (cat # 430207) ELISA kits	30 minutes before the anesthesia administration and 5 minutes before extubation