NCT04854252

Inflammatory Response to Opioid Versus Opioid Free Anesthesia

Completed NA Last updated 22 April 2021

What this trial tests

NA trial testing Fentanyl in Morbid Obesity in 40 participants. Completed in 29 March 2021.

Timeline

12 November 2020

Primary endpoint
29 March 2021

29 March 2021

Quick facts

Lead sponsor	University of Guadalajara
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	12 November 2020
Primary completion	29 March 2021
Estimated completion	29 March 2021
Sites	1 location across Mexico

Drugs / interventions tested

• Fentanyl (fentanyl) — full drug profile →

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →
• Opioid Use — all drugs for Opioid Use →
• Fentanyl Adverse Reaction — all drugs for Fentanyl Adverse Reaction →
• Cytokine Storm — all drugs for Cytokine Storm →

Sponsor

University of Guadalajara

Who can join

Adults 18 to 65, any sex, with Morbid Obesity or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A comparison of opioid-containing anesthesia versus opioid-free anesthesia using the Cortínez-Sepúlveda model on differential cytokine responses in obese patients undergoing gastric bypass surgery: a randomized controlled trial.
   Campos-Pérez W, Ramírez-Plascencia L, Pérez-Robles M, Rivera-Valdés JJ, et al · · 2022 · cited 8× · PMID 36114460 · DOI 10.1186/s12871-022-01838-8
2. 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: a randomized controlled trial
   Martínez-López E, Campos-Pérez W, Ramírez-Plascencia L, Pérez-Robles M, et al · · 2022 · DOI 10.21203/rs.3.rs-1301535/v1