ObesityMRICBx3NCT06915558
Modulation of the Inflammatory Response in Bariatric Surgery
An observational study of Obesity and Bariatric Surgery Candidate, run by Hospital HM Nou Delfos at 1 site in Spain.
Trial summary
This study will evaluate how different anesthesia techniques affect inflammation after bariatric surgery. Patients will be randomly assigned to receive one of three approaches: opioid-free anesthesia, intravenous anesthesia with opioids, or inhalational anesthesia with opioids. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate, Inflammation
- What is being tested?
- Opioid-Free Anesthesia (OFA), Opioid-Based Intravenous Anesthesia (OBA-IV) and Opioid-Based Inhalational Anesthesia (OBA-Inh)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2024to 2 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of adult patients undergoing elective bariatric surgery at HM Nou Delfos Hospital. Patients will be selected according to specific inclusion and exclusion criteria to ensure homogeneous groups for the comparison of inflammatory response to different anesthetic techniques. All participants will undergo preoperative screening, intraoperative monitoring, and postoperative follow-up to evaluate primary and secondary outcomes.
Who may be able to join
- Patients scheduled for bariatric surgery.
- Age 18-65 years.
- BMI ≥ 30 kg/m².
- ASA physical status II-III.
Who cannot join
- Pregnancy or breastfeeding.
- Chronic opioid use before surgery.
- Severe renal or hepatic failure.
- Uncontrolled psychiatric disorders.
- Significant intraoperative complications requiring protocol deviation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital HM Nou Delfos
Barcelona, Barcelona, 08023
Hipolito Labandeyra Gonzalez, Anesthesiologist, +34696055181, hipolitolabandeyra@gmail.com
Gregory Contreras-Pérez, Anesthesiologist
About this study
Official title: Modulation of the Inflammatory Response to Surgical Trauma: Comparison of Three Anesthetic Techniques in Bariatric Surgery Patients
This study will evaluate how different anesthesia techniques affect inflammation after bariatric surgery. Patients will be randomly assigned to receive one of three approaches: opioid-free anesthesia, intravenous anesthesia with opioids, or inhalational anesthesia with opioids.
The study will measure blood levels of inflammation-related substances (such as IL-6, CRP, cortisol, ESR , WBC and lactate) at several time points before and after surgery. Heart rate variability will also be monitored as an indicator of the body's stress response.
The results may help identify anesthesia strategies that reduce inflammation and improve recovery in patients undergoing bariatric surgery.
Read the detailed description
This is a prospective, randomized, double-blind, comparative observational study designed to assess the perioperative inflammatory response in patients undergoing bariatric surgery under three anesthetic techniques: opioid-free anesthesia (OFA), opioid-based intravenous anesthesia (OBA-IV), and opioid-based inhalational anesthesia (OBA-Inh).
A total of 90 patients scheduled for elective laparoscopic bariatric surgery will be enrolled and randomized using computer-generated allocation into three equal groups (n=30 each). Allocation concealment will be maintained using sealed opaque envelopes. Blinding will involve both the patients and outcome assessors; anesthesiologists administering the interventions will not be blinded due to the nature of the techniques.
The study's primary focus is to evaluate the perioperative modulation of inflammation through quantification of biomarkers including interleukin-6 (IL-6), C-reactive protein (CRP), serum cortisol, leukocyte count (WBC), erythrocyte sedimentation rate (ESR) and lactate. Heart rate variability (HRV) will be continuously monitored as a surrogate marker for autonomic modulation of the inflammatory response.
Biomarkers will be sampled at three time points: preoperative baseline (T0), at the end of surgery (T1), and 24 hours postoperatively (T2). HRV data will be collected from induction to the end of surgical intervention using a non invasive monitoring system with time- and frequency-domain analysis.
Secondary outcomes include intraoperative and postoperative analgesic consumption, pain intensity assessed by visual analog scale (VAS), sedation scores using the Ramsay Agitation-Sedation Scale (RASS), incidence of opioid-related side effects (nausea, vomiting, respiratory depression), patient satisfaction (via validated questionnaire), and length of hospital stay.
Sample size was calculated based on preliminary data detecting a clinically significant difference in IL-6 levels, assuming an alpha of 0.05 and power of 0.8. Data will be analyzed using ANOVA or Kruskal-Wallis test for continuous variables, chi-square for categorical variables, and multivariate regression models to adjust for potential confounders.
This study aims to identify anesthetic strategies that minimize systemic inflammation and autonomic dysregulation in the bariatric surgical population, with potential applications in broader surgical settings.
- Conditions
- Obesity, Bariatric Surgery Candidate, Inflammation, Postoperative Pain, Opioid-Free Anesthesia, Heart Rate Variability
- Being tested
- Opioid-Free Anesthesia (OFA), Opioid-Based Intravenous Anesthesia (OBA-IV), Opioid-Based Inhalational Anesthesia (OBA-Inh)
- Keywords
- Opioid-Free Anesthesia, Opioid-Based Anesthesia, Inflammatory Markers, Surgical Stress Response, heart rate variability
- Medical subject headings
- Obesity, Inflammation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Free Anesthesia (OFA)Procedure or surgery
Also called Multimodal Opioid-Free Anesthesia
Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.
Opioid-Based Intravenous Anesthesia (OBA-IV)Procedure or surgery
Also called IV Opioid-Based Anesthesia
Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.
Opioid-Based Inhalational Anesthesia (OBA-Inh)Procedure or surgery
Also called Inhalational Opioid-Based Anesthesia
Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | Patients in this group will receive opioid-free anesthesia (OFA) using a multimodal analgesic approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids will be administered. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and heart rate variability (HRV) will be measured to assess the inflammatory response. Receives: Procedure: Opioid-Free Anesthesia (OFA) | |
| Opioid-Based Anesthesia - Intravenous (OBA-IV) | Patients in this group will receive opioid-based intravenous anesthesia (OBA-IV) with propofol, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be administered intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be assessed to compare inflammatory responses between opioid-based and opioid-free techniques. Receives: Procedure: Opioid-Based Intravenous Anesthesia (OBA-IV) | |
| Opioid-Based Anesthesia - Inhalational (OBA-Inh) | Patients in this group will receive opioid-based inhalational anesthesia (OBA-Inh) using sevoflurane, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be used intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be analyzed to evaluate differences in the inflammatory response among the three anesthetic techniques. Receives: Procedure: Opioid-Based Inhalational Anesthesia (OBA-Inh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IL-6 Level
Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
C-reactive Protein (CRP) Level
Measurement in mg/L to assess systemic inflammation.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Serum Cortisol Level
Measurement in μg/dL.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Heart Rate Variability (HRV) as an Inflammatory Marker
Heart Rate Variability (HRV) as an Inflammatory Marker and its correlation with blood levels of inflammatory markers Heart Rate Variability (HRV) as an Indicator of Inflammatory Response
Measured: Collected continuosly from the induction of the anesthesia until the end of surgery
Serum Lactate Level
Measurement in mmol/L as a marker of metabolic response.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Erythrocyte Sedimentation Rate (ESR)
Measurement of ESR in mm/h to assess systemic inflammation.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Differential White blood Cell count (WBC).
Measurement of total white blood cell count in peripheral blood, expressed in thousands of cells per microliter (10³/μL). Assessment of the percentage distribution of white blood cell subtypes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils, expressed as a percentage of total leukocytes.
Measured: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Secondary outcomes (4)
Postoperative Pain Evaluation Using Visual Analog Scale (VAS)
Assessment of pain intensity using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Measured: hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward
Postoperative Sedation Level Using Ramsay Sedation Scale
Evaluation of sedation using the Ramsay Sedation Scale, which ranges from 1 (anxious and agitated) to 6 (no response to stimulus). Higher scores indicate deeper levels of sedation.
Measured: immediately after surgery, and hourly during the first 4 hours in the recovery area, and at 12 and 24 hours in the hospitalization ward
Incidence of Postoperative Complications
Measurement of total hospital stay (in days) after surgery.
Measured: 24 hours post-surgery.
Patient Satisfaction with Anesthetic Technique
Evaluation of patient satisfaction using a standardized 5-point Likert scale questionnaire (1 = very dissatisfied; 5 = very satisfied) regarding anesthesia and overall recovery experience.
Measured: 24 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start2 Dec 2024
- Primary completion2 Dec 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital HM Nou Delfos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HIPÓLITO LABANDEYRA GONZALEZ, Hospital HM Nou Delfos
- Investigators
- Gregory Contreras-Pérez, Anesthesiologist, Principal investigator, Hospital HM Nou Delfos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915558
- Sponsor's protocol ID
- 25.02.2467-GHM
- Acronym
- MRICBx3
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy regulations and ethical considerations. Data will only be accessible to the research team and authorized personnel as per institutional and regulatory guidelines.
Publications
Heil LBB, Silva PL, Pelosi P, Rocco PRM. Immunomodulatory effects of anesthetics in obese patients. World J Crit Care Med. 2017 Aug 4;6(3):140-152. doi: 10.5492/wjccm.v6.i3.140. eCollection 2017 Aug 4.
PubMed 28828299Alsumali A, Eguale T, Bairdain S, Samnaliev M. Cost-Effectiveness Analysis of Bariatric Surgery for Morbid Obesity. Obes Surg. 2018 Aug;28(8):2203-2214. doi: 10.1007/s11695-017-3100-0.
PubMed 29335933Lin YT, Wu HT, Tsao J, Yien HW, Hseu SS. Time-varying spectral analysis revealing differential effects of sevoflurane anaesthesia: non-rhythmic-to-rhythmic ratio. Acta Anaesthesiol Scand. 2014 Feb;58(2):157-67. doi: 10.1111/aas.12251.
PubMed 24410106Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.
PubMed 21051493Wennervirta J, Hynynen M, Koivusalo AM, Uutela K, Huiku M, Vakkuri A. Surgical stress index as a measure of nociception/antinociception balance during general anesthesia. Acta Anaesthesiol Scand. 2008 Sep;52(8):1038-45. doi: 10.1111/j.1399-6576.2008.01687.x.
PubMed 18840101Lisowska B, Jakubiak J, Siewruk K, Sady M, Kosson D. Which idea is better with regard to immune response? Opioid anesthesia or opioid free anesthesia. J Inflamm Res. 2020 Nov 5;13:859-869. doi: 10.2147/JIR.S275986. eCollection 2020.
PubMed 33177861Campos-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 36114460Ahmed SA, Abdelghany MS, Afandy ME. The effect of opioid-free anesthesia on the post-operative opioid consumption in laparoscopic bariatric surgeries: A randomized controlled double-blind study. J Opioid Manag. 2022 Jan-Feb;18(1):47-56. doi: 10.5055/jom.2022.0694.
PubMed 35238013Schneemilch CE, Ittenson A, Ansorge S, Hachenberg T, Bank U. Effect of 2 anesthetic techniques on the postoperative proinflammatory and anti-inflammatory cytokine response and cellular immune function to minor surgery. J Clin Anesth. 2005 Nov;17(7):517-27. doi: 10.1016/j.jclinane.2004.12.017.
PubMed 16297751Lin E, Calvano SE, Lowry SF. Inflammatory cytokines and cell response in surgery. Surgery. 2000 Feb;127(2):117-26. doi: 10.1067/msy.2000.101584.
PubMed 10686974Schumann R. Anaesthesia for bariatric surgery. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):83-93. doi: 10.1016/j.bpa.2010.12.006.
PubMed 21516916Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31.
PubMed 28721154Gregor MF, Hotamisligil GS. Inflammatory mechanisms in obesity. Annu Rev Immunol. 2011;29:415-45. doi: 10.1146/annurev-immunol-031210-101322.
PubMed 21219177
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Inflammatory Response to Surgical Trauma: Comparison of Three Anesthetic Techniques in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT06915558
- Acronym / sponsor ID
- MRICBx3 / 25.02.2467-GHM
- Conditions
- Obesity, Bariatric Surgery Candidate, Inflammation, Postoperative Pain, Opioid-Free Anesthesia, Heart Rate Variability
- Keywords
- Opioid-Free Anesthesia, Opioid-Based Anesthesia, Inflammatory Markers, Surgical Stress Response, heart rate variability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital HM Nou DelfosUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 8 Apr 2025 (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.
This study will evaluate how different anesthesia techniques affect inflammation after bariatric surgery. Patients will be randomly assigned to receive one of three approaches: opioid-free anesthesia, intravenous anesthesia with opioids, or inhalational anesthesia with opioids.
The study will measure blood levels of inflammation-related substances (such as IL-6, CRP, cortisol, ESR , WBC and lactate) at several time points before and after surgery. Heart rate variability will also be monitored as an indicator of the body's stress response.
The results may help identify anesthesia strategies that reduce inflammation and improve recovery in patients undergoing bariatric surgery.
Detailed description
This is a prospective, randomized, double-blind, comparative observational study designed to assess the perioperative inflammatory response in patients undergoing bariatric surgery under three anesthetic techniques: opioid-free anesthesia (OFA), opioid-based intravenous anesthesia (OBA-IV), and opioid-based inhalational anesthesia (OBA-Inh).
A total of 90 patients scheduled for elective laparoscopic bariatric surgery will be enrolled and randomized using computer-generated allocation into three equal groups (n=30 each). Allocation concealment will be maintained using sealed opaque envelopes. Blinding will involve both the patients and outcome assessors; anesthesiologists administering the interventions will not be blinded due to the nature of the techniques.
The study's primary focus is to evaluate the perioperative modulation of inflammation through quantification of biomarkers including interleukin-6 (IL-6), C-reactive protein (CRP), serum cortisol, leukocyte count (WBC), erythrocyte sedimentation rate (ESR) and lactate. Heart rate variability (HRV) will be continuously monitored as a surrogate marker for autonomic modulation of the inflammatory response.
Biomarkers will be sampled at three time points: preoperative baseline (T0), at the end of surgery (T1), and 24 hours postoperatively (T2). HRV data will be collected from induction to the end of surgical intervention using a non invasive monitoring system with time- and frequency-domain analysis.
Secondary outcomes include intraoperative and postoperative analgesic consumption, pain intensity assessed by visual analog scale (VAS), sedation scores using the Ramsay Agitation-Sedation Scale (RASS), incidence of opioid-related side effects (nausea, vomiting, respiratory depression), patient satisfaction (via validated questionnaire), and length of hospital stay.
Sample size was calculated based on preliminary data detecting a clinically significant difference in IL-6 levels, assuming an alpha of 0.05 and power of 0.8. Data will be analyzed using ANOVA or Kruskal-Wallis test for continuous variables, chi-square for categorical variables, and multivariate regression models to adjust for potential confounders.
This study aims to identify anesthetic strategies that minimize systemic inflammation and autonomic dysregulation in the bariatric surgical population, with potential applications in broader surgical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | – | Procedure: Opioid-Free Anesthesia (OFA)Patients in this group will receive opioid-free anesthesia (OFA) using a multimodal analgesic approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids will be administered. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and heart rate variability (HRV) will be measured to assess the inflammatory response. |
| Opioid-Based Anesthesia - Intravenous (OBA-IV) | – | Procedure: Opioid-Based Intravenous Anesthesia (OBA-IV)Patients in this group will receive opioid-based intravenous anesthesia (OBA-IV) with propofol, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be administered intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be assessed to compare inflammatory responses between opioid-based and opioid-free techniques. |
| Opioid-Based Anesthesia - Inhalational (OBA-Inh) | – | Procedure: Opioid-Based Inhalational Anesthesia (OBA-Inh)Patients in this group will receive opioid-based inhalational anesthesia (OBA-Inh) using sevoflurane, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be used intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be analyzed to evaluate differences in the inflammatory response among the three anesthetic techniques. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective bariatric surgery at HM Nou Delfos Hospital. Patients will be selected according to specific inclusion and exclusion criteria to ensure homogeneous groups for the comparison of inflammatory response to different anesthetic techniques. All participants will undergo preoperative screening, intraoperative monitoring, and postoperative follow-up to evaluate primary and secondary outcomes.
Key inclusion criteria (4 listed)
- Patients scheduled for bariatric surgery.
- Age 18-65 years.
- BMI ≥ 30 kg/m².
- ASA physical status II-III.
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding.
- Chronic opioid use before surgery.
- Severe renal or hepatic failure.
- Uncontrolled psychiatric disorders.
- Significant intraoperative complications requiring protocol deviation.
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 |
|---|---|---|
| Opioid-Free Anesthesia (OFA)Also: Multimodal Opioid-Free AnesthesiaOpioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered. | Procedure or surgery | Opioid-Free Anesthesia (OFA) |
| Opioid-Based Intravenous Anesthesia (OBA-IV)Also: IV Opioid-Based AnesthesiaStandard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade. | Procedure or surgery | Opioid-Based Anesthesia - Intravenous (OBA-IV) |
| Opioid-Based Inhalational Anesthesia (OBA-Inh)Also: Inhalational Opioid-Based AnesthesiaStandard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade. | Procedure or surgery | Opioid-Based Anesthesia - Inhalational (OBA-Inh) |
Primary outcome
Serum IL-6 Level
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.
C-reactive Protein (CRP) Level
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in mg/L to assess systemic inflammation.
Serum Cortisol Level
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in μg/dL.
Heart Rate Variability (HRV) as an Inflammatory Marker
Time frame: Collected continuosly from the induction of the anesthesia until the end of surgery
Heart Rate Variability (HRV) as an Inflammatory Marker and its correlation with blood levels of inflammatory markers Heart Rate Variability (HRV) as an Indicator of Inflammatory Response
Serum Lactate Level
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in mmol/L as a marker of metabolic response.
Erythrocyte Sedimentation Rate (ESR)
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement of ESR in mm/h to assess systemic inflammation.
Differential White blood Cell count (WBC).
Time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement of total white blood cell count in peripheral blood, expressed in thousands of cells per microliter (10³/μL). Assessment of the percentage distribution of white blood cell subtypes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils, expressed as a percentage of total leukocytes.
4 secondary outcomes
Postoperative Pain Evaluation Using Visual Analog Scale (VAS)
Time frame: hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward
Postoperative Sedation Level Using Ramsay Sedation Scale
Time frame: immediately after surgery, and hourly during the first 4 hours in the recovery area, and at 12 and 24 hours in the hospitalization ward
Incidence of Postoperative Complications
Time frame: 24 hours post-surgery.
Patient Satisfaction with Anesthetic Technique
Time frame: 24 hours post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 28828299Heil LBB, Silva PL, Pelosi P, Rocco PRM. Immunomodulatory effects of anesthetics in obese patients. World J Crit Care Med. 2017 Aug 4;6(3):140-152. doi: 10.5492/wjccm.v6.i3.140. eCollection 2017 Aug 4.
- Background: PubMed 29335933Alsumali A, Eguale T, Bairdain S, Samnaliev M. Cost-Effectiveness Analysis of Bariatric Surgery for Morbid Obesity. Obes Surg. 2018 Aug;28(8):2203-2214. doi: 10.1007/s11695-017-3100-0.
- Background: PubMed 24410106Lin YT, Wu HT, Tsao J, Yien HW, Hseu SS. Time-varying spectral analysis revealing differential effects of sevoflurane anaesthesia: non-rhythmic-to-rhythmic ratio. Acta Anaesthesiol Scand. 2014 Feb;58(2):157-67. doi: 10.1111/aas.12251.
- Background: PubMed 21051493Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.
- Background: PubMed 18840101Wennervirta J, Hynynen M, Koivusalo AM, Uutela K, Huiku M, Vakkuri A. Surgical stress index as a measure of nociception/antinociception balance during general anesthesia. Acta Anaesthesiol Scand. 2008 Sep;52(8):1038-45. doi: 10.1111/j.1399-6576.2008.01687.x.
- Background: PubMed 33177861Lisowska B, Jakubiak J, Siewruk K, Sady M, Kosson D. Which idea is better with regard to immune response? Opioid anesthesia or opioid free anesthesia. J Inflamm Res. 2020 Nov 5;13:859-869. doi: 10.2147/JIR.S275986. eCollection 2020.
- Background: 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.
- Background: PubMed 35238013Ahmed SA, Abdelghany MS, Afandy ME. The effect of opioid-free anesthesia on the post-operative opioid consumption in laparoscopic bariatric surgeries: A randomized controlled double-blind study. J Opioid Manag. 2022 Jan-Feb;18(1):47-56. doi: 10.5055/jom.2022.0694.
- Background: PubMed 16297751Schneemilch CE, Ittenson A, Ansorge S, Hachenberg T, Bank U. Effect of 2 anesthetic techniques on the postoperative proinflammatory and anti-inflammatory cytokine response and cellular immune function to minor surgery. J Clin Anesth. 2005 Nov;17(7):517-27. doi: 10.1016/j.jclinane.2004.12.017.
- Background: PubMed 10686974Lin E, Calvano SE, Lowry SF. Inflammatory cytokines and cell response in surgery. Surgery. 2000 Feb;127(2):117-26. doi: 10.1067/msy.2000.101584.
- Background: PubMed 21516916Schumann R. Anaesthesia for bariatric surgery. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):83-93. doi: 10.1016/j.bpa.2010.12.006.
- Background: PubMed 28721154Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy regulations and ethical considerations. Data will only be accessible to the research team and authorized personnel as per institutional and regulatory guidelines.
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Gregory Contreras-Pérez, Anesthesiologist principal investigator
Hospital HM Nou Delfos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery Candidate, run by Hospital HM Nou Delfos at 1 site in Spain.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hipolito Labandeyra Gonzalez, Anesthesiologist (+34696055181, hipolitolabandeyra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IL-6 Level (time frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.). The study lists 7 primary outcomes in all. 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 NCT06915558, which also lists 13 linked publications.
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 8 Apr 2025.