Morbid ObesityNCT04854252
Inflammatory Response to Opioid Versus Opioid Free Anesthesia
A study testing Fentanyl in people with Morbid Obesity and Opioid Use, run by University of Guadalajara at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Opioid Use, Fentanyl Adverse Reaction
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 12 Nov 2020to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Fentanyl
- Keywords
- Morbid obesity, Gastric bypass, Opioid containing anesthesia, Opioid free anesthesia, Cytokines
- Medical subject headings
- Obesity, Morbid, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes before the anesthesia administration and 5 minutes before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start12 Nov 2020
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERIKA MARTINEZ-LOPEZ, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854252
- Sponsor's protocol ID
- 09042021
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36114460
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04854252
- Acronym / sponsor ID
- 09042021
- Conditions
- Morbid Obesity, Opioid Use, Fentanyl Adverse Reaction, Cytokine Storm
- Keywords
- Morbid obesity, Gastric bypass, Opioid containing anesthesia, Opioid free anesthesia, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inflammatory response to opioid vs opioid free anesthesia | Experimental | Drug: FentanylPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylTIVA 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 | Drug | Inflammatory response to opioid vs opioid free anesthesia |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 36114460Campos-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Morbid Obesity and Opioid Use, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.