Morbid Obesity Requiring Bariatric SurgeryPhase 4NCT07073846
Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
A Phase 4 study testing Intravenous Lidocaine infusion + Standard Anesthesia, Intravenous Dexmedetomidine infusion + Standard Anesthesia and Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia in people with Morbid Obesity Requiring Bariatric Surgery and Postoperative Pain, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.
Trial summary
The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity Requiring Bariatric Surgery, Postoperative Pain, Postoperative Pain Management
- What is being tested?
- Intravenous Lidocaine infusion + Standard Anesthesia, Intravenous Dexmedetomidine infusion + Standard Anesthesia and Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesMexico
- Study dates
- 6 Oct 2025to 1 Jul 2027
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 - 60 years
- Male or female
- Elective laparoscopic bariatric surgery
- Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h
- ASA physical-status II or III
Who cannot join
- Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks).
- Current substance abuse or illicit drug use.
- Previous abdominal surgery within the last 6 months.
- Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists.
- Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I/III anti-arrhythmic drugs.
- Estimated glomerular filtration rate (eGFR) < 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment).
Show all 16Show fewer
- Severe hepatic impairment (Child-Pugh C).
- Pregnancy or lactation.
- Chronic opioid consumption > 30 mg oral morphine equivalents per day for > 4 weeks
- Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion.
- Patient cannot communicate
- Patient does not want to fill in the questionnaire
- Participation in another interventional study within the past 30 days.
- Intra-operative conversion to open surgery.
- Insufficient biological sample for biomarker analysis.
- Premature discontinuation of the study drug during surgery for any reason that, in the judgement of the treating anaesthesiologist or investigators, prevents adequate exposure or assessment of safety variables (e.g., major haemorrhage > 200 mL, anaphylactic shock, failed intubation, inability to extubate, severe metabolic/respiratory acidosis, transfer to ICU while intubated).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico2 sites, 2 recruiting
- Recruiting
Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico City, 06720
Dulce María Rascón Martínez, MSc, 5542410378, drarascon@hotmail.com
Arnulfo Calixto Flores, Researcher, +525534590203, drrufo@hotmail.com
- Recruiting
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI
Mexico City, Mexico City, 06720
Dulce M Rascón Martínez, MD, MSc, + 52 55 5627 6900 ext. 22638, dradulcerascon@gmail.com
Arnulfo Calixto Flores, MD, PhD, + 52 55 5627 6900 ext. 21607, drrufo@hotmail.com
About this study
Official title: Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery
The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity.
The main questions it aims to answer are:
Read more
- Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)?
- Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo?
Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best.
Participants will:
- Receive an intravenous infusion of their assigned study drug(s) during surgery.
- Provide three small blood samples (before surgery, immediately after, and three hours after).
- Complete a short pain questionnaire (IPOQ) 24 hours after surgery.
Read the detailed description
Obesity is associated with chronic low-grade inflammation and persistent oxidative stress. Laparoscopic bariatric surgery-although highly effective for weight reduction-triggers an acute inflammatory cascade and a burst of reactive oxygen species that can amplify post-operative pain and delay functional recovery.
Intravenous lidocaine stabilises voltage-gated Na+ channels, limits ectopic neuronal firing and inhibits neutrophil priming; it also down-regulates the release of pro-inflammatory cytokines in abdominal procedures. Dexmedetomidine, a highly selective α2-adrenergic agonist, produces sedation and analgesia while attenuating sympathetic outflow, thereby reducing surgical catecholamine surges and cytokine release. Pre-clinical and clinical synergy studies indicate that combining these two agents (LIDEX) can provide additive anti-hyperalgesic, anti-inflammatory and antioxidant effects without increasing cardiovascular risk when each is dosed within its established therapeutic window.
In this protocol, a weight-adjusted intra-operative infusion of lidocaine plus dexmedetomidine is administered during bariatric surgery and compared with each single agent and saline. Peri-operative venous samples are collected for mechanistic profiling of systemic inflammatory and redox responses, and patient-reported pain is captured after surgery using a validated instrument. Haemodynamic parameters are continuously monitored to detect potential lidocaine toxicity or dexmedetomidine-related bradycardia and hypotension; predefined rescue algorithms are applied if thresholds are exceeded.
The study is designed to clarify whether the LIDEX combination can blunt the acute inflammatory-oxidative surge thought to drive sustained pain and metabolic stress after bariatric surgery, thereby informing future enhanced-recovery protocols that integrate multimodal analgesia with metabolic optimisation strategies.
- Conditions
- Morbid Obesity Requiring Bariatric Surgery, Postoperative Pain, Postoperative Pain Management, Postoperative Analgesia, Postoperative Adjuvant Treatment, Postoperative Inflammatory Markers
- Being tested
- Intravenous Lidocaine infusion + Standard Anesthesia, Intravenous Dexmedetomidine infusion + Standard Anesthesia, Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia, 0.9 % Saline Placebo + Standard Anesthesia
- Keywords
- Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Laparoscopic Gastric Bypass, Pain Management, Lidocaine-Dexmedetomidine, Multimodal Analgesia, Inflammatory Cytokines, Oxidative Stress, Opioid-sparing Anesthesia, Enhanced Recovery (ERAS), Postoperarive Oxidative Stress
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Lidocaine infusion + Standard AnesthesiaDrug
Also called Xylocaine®, Lignocaine
Continuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion.
Intravenous Dexmedetomidine infusion + Standard AnesthesiaDrug
Also called Precedex®, Dexdor®, DEX
Continuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion.
Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard AnesthesiaDrug
Also called LIDEX, Lidocaine-Dexmedetomidine cocktail, LID + DEX
Single syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure.
0.9 % Saline Placebo + Standard AnesthesiaDrug
Also called Normal Saline, Sodium Chloride 0.9 %, Serum Saline, 0.9 % NaCl
Volume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Infusion (LID) | Active comparator | Intra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion. Receives: Drug: Intravenous Lidocaine infusion + Standard Anesthesia |
| Dexmedetomidine Infusion (DEX) | Active comparator | Intra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure. Receives: Drug: Intravenous Dexmedetomidine infusion + Standard Anesthesia |
| Lidocaine + Dexmedetomidine (LIDEX) | Experimental | Concurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure. Receives: Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia |
| Saline Placebo | Placebo comparator | IV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance. Receives: Drug: 0.9 % Saline Placebo + Standard Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain patient perception using the Spanish International Pain Outcomes Questionnaire (IPOQ). This questionnaire includes multiple items assessed on a numerical rating scale (NRS) from 0 to 10.
- For most items (e.g., pain intensity, interference with activities, emotional impact), higher scores indicate worse outcomes.
- For items such as pain relief and satisfaction, higher scores indicate better outcomes.
Items include:
- Highest and lowest pain intensity experienced since surgery
- Proportion of time spent in pain
- How pain limited physical activities (e.g., coughing, moving, walking)
- Impact of pain on mood and emotional well-being
- Adverse effects attributed to pain medication (e.g., nausea, dizziness)
- Overall degree of pain relief obtained
- Desire for additional analgesic treatment
- Clarity and usefulness of information received about pain therapy
- Extent of patient involvement in treatment decisions
- Global satisfaction with pain management
- Use of non-pharmacological methods for pain relief
- Presence of pre-existing pain before hospital admission
Measured: 24 hours post-operative
Secondary outcomes (2)
Change in pro-inflammatory cytokine (IL-1β, IL-6, TNF-α) and anti -inflammatory IL-10 panel
Serum concentrations of interleukin-1 beta (IL-1β), interleukin-6 (IL-6), and tumour necrosis factor-alpha (TNF-α) measured by multiplex ELISA (pg mL-¹). The primary comparison is the change from baseline and the area-under-curve (AUC₀-₃ h) across the four treatment arms; lower values indicate a reduced systemic inflammatory response.
Measured: Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively
Change in oxidative-stress marker panel (MDA, GSH/GSSG ratio, SOD, catalase, neutrophil respiratory burst)
Plasma malondialdehyde (MDA, µmol L-¹; TBARS assay), glutathione redox ratio (GSH/GSSG), superoxide-dismutase activity (SOD, U mL-¹) and catalase activity (U mL-¹) will be quantified with spectrophotometric/enzymatic methods. Neutrophil respiratory burst (reactive oxygen-species production) will be assessed by flow cytometry using DCFH-DA and expressed as mean fluorescence intensity (MFI). Change from baseline and the area-under-the-curve (AUC₀-3 h) will be compared across the four study arms; lower MDA/MFI and higher antioxidant indices indicate less oxidative stress.
Measured: Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start6 Oct 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Morbid Obesity Requiring Bariatric SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, quadruple-masked, four-arm parallel design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dulce Maria Rascon Martinez, Instituto Mexicano del Seguro Social
- Investigators
- Dulce María Rascón Martínez, Prof MD, MSc, Principal investigator, Instituto Mexicano del Seguro SocialArnulfo Calixto Flores, Prof MD, PhD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073846
- Sponsor's protocol ID
- R-2025-3601-197
- Status last verified
- Nov 2025
- First submitted
- 30 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that support the results reported in this study will be shared. This includes primary outcome data (IPOPQ responses), inflammatory cytokine levels (IL-1β, IL-6, TNF-α, IL-10), oxidative stress markers (MDA, SOD, catalase, GSH/GSSG ratio), and neutrophil respiratory burst results. All data will be anonymized and coded to protect participant confidentiality.
Publications
Xie D, Wang F, Wen W, Li H. Postoperative analgesic effect of intravenous coinjection of lidocaine and dexmedetomidine in gynaecological surgery: a systematic review and meta-analysis. BMJ Open. 2024 Dec 11;14(12):e091904. doi: 10.1136/bmjopen-2024-091904.
PubMed 39663167Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.
PubMed 34704710Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j.soard.2022.03.002. Epub 2022 Mar 9.
PubMed 35422388de Oliveira CMB, Coelho LMG, Valadao JA, Moura ECR, da Silva AAM, de Lima RC, Brunialti MKC, Salomao R, da Cunha Leal P, Sakata RK. Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty. Obes Surg. 2020 Oct;30(10):3912-3918. doi: 10.1007/s11695-020-04748-1. Epub 2020 Jun 12.
PubMed 32533519Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.
PubMed 33407156Lai Y, Chen Q, Xiang C, Li G, Wei K. Comparison of the Effects of Dexmedetomidine and Lidocaine on Stress Response and Postoperative Delirium of Older Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial. Clin Interv Aging. 2023 Aug 3;18:1275-1283. doi: 10.2147/CIA.S419835. eCollection 2023.
PubMed 37554513Chen X, Chen Q, Qin Z, Alam A, Zhao H, West R, Liu X, Li J, Li X, Yi B, Ma D, Gu J. Dexmedetomidine Attenuates Inflammation in Elderly Patients Following Major Hepatobiliary and Pancreatic Surgery: A Randomized Clinical Trial. Clin Interv Aging. 2024 May 29;19:981-991. doi: 10.2147/CIA.S455987. eCollection 2024.
PubMed 38827237Ohta Y, Miyamoto K, Kawazoe Y, Yamamura H, Morimoto T. Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial. Crit Care. 2020 Aug 10;24(1):493. doi: 10.1186/s13054-020-03207-8.
PubMed 32778146Zhang J, Wang Z, Wang Y, Zhou G, Li H. The effect of dexmedetomidine on inflammatory response of septic rats. BMC Anesthesiol. 2015 May 1;15:68. doi: 10.1186/s12871-015-0042-8.
PubMed 25929655Avci O, Taskiran AS, Gundogdu O. Dexmedetomidina, un agonista de α2, incrementa el efecto analgésico de la morfina y reduce el desarrollo de tolerancia a la morfina suprimiendo el estrés oxidativo y la vía de señalización de TNF/IL-1 en ratas. Rev Esp Anestesiol Reanim
Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
PubMed 26903197Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.
PubMed 32240402Lai YC, Wang WT, Hung KC, Chen JY, Wu JY, Chang YJ, Lin CM, Chen IW. Impact of intravenous dexmedetomidine on postoperative gastrointestinal function recovery: an updated meta-analysis. Int J Surg. 2024 Mar 1;110(3):1744-1754. doi: 10.1097/JS9.0000000000000988.
PubMed 38085848Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD010358. doi: 10.1002/14651858.CD010358.pub2.
PubMed 26889627Lin S, Jin P, Shao C, Lu W, Xiang Q, Jiang Z, Zhang Y, Bian J. Lidocaine attenuates lipopolysaccharide-induced inflammatory responses and protects against endotoxemia in mice by suppressing HIF1alpha-induced glycolysis. Int Immunopharmacol. 2020 Mar;80:106150. doi: 10.1016/j.intimp.2019.106150. Epub 2020 Jan 17.
PubMed 31958741
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07073846
- Acronym / sponsor ID
- R-2025-3601-197
- Conditions
- Morbid Obesity Requiring Bariatric Surgery, Postoperative Pain, Postoperative Pain Management, Postoperative Analgesia, Postoperative Adjuvant Treatment, Postoperative Inflammatory Markers
- Keywords
- Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Laparoscopic Gastric Bypass, Pain Management, Lidocaine-Dexmedetomidine, Multimodal Analgesia, Inflammatory Cytokines, Oxidative Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 18 Jul 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.
The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity.
The main questions it aims to answer are:
- Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)?
- Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo?
Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best.
Participants will:
- Receive an intravenous infusion of their assigned study drug(s) during surgery.
- Provide three small blood samples (before surgery, immediately after, and three hours after).
- Complete a short pain questionnaire (IPOQ) 24 hours after surgery.
Detailed description
Obesity is associated with chronic low-grade inflammation and persistent oxidative stress. Laparoscopic bariatric surgery-although highly effective for weight reduction-triggers an acute inflammatory cascade and a burst of reactive oxygen species that can amplify post-operative pain and delay functional recovery.
Intravenous lidocaine stabilises voltage-gated Na+ channels, limits ectopic neuronal firing and inhibits neutrophil priming; it also down-regulates the release of pro-inflammatory cytokines in abdominal procedures. Dexmedetomidine, a highly selective α2-adrenergic agonist, produces sedation and analgesia while attenuating sympathetic outflow, thereby reducing surgical catecholamine surges and cytokine release. Pre-clinical and clinical synergy studies indicate that combining these two agents (LIDEX) can provide additive anti-hyperalgesic, anti-inflammatory and antioxidant effects without increasing cardiovascular risk when each is dosed within its established therapeutic window.
In this protocol, a weight-adjusted intra-operative infusion of lidocaine plus dexmedetomidine is administered during bariatric surgery and compared with each single agent and saline. Peri-operative venous samples are collected for mechanistic profiling of systemic inflammatory and redox responses, and patient-reported pain is captured after surgery using a validated instrument. Haemodynamic parameters are continuously monitored to detect potential lidocaine toxicity or dexmedetomidine-related bradycardia and hypotension; predefined rescue algorithms are applied if thresholds are exceeded.
The study is designed to clarify whether the LIDEX combination can blunt the acute inflammatory-oxidative surge thought to drive sustained pain and metabolic stress after bariatric surgery, thereby informing future enhanced-recovery protocols that integrate multimodal analgesia with metabolic optimisation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, quadruple-masked, four-arm parallel design.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Infusion (LID) | Active comparator | Drug: Intravenous Lidocaine infusion + Standard AnesthesiaIntra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion. |
| Dexmedetomidine Infusion (DEX) | Active comparator | Drug: Intravenous Dexmedetomidine infusion + Standard AnesthesiaIntra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure. |
| Lidocaine + Dexmedetomidine (LIDEX) | Experimental | Drug: Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard AnesthesiaConcurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure. |
| Saline Placebo | Placebo comparator | Drug: 0.9 % Saline Placebo + Standard AnesthesiaIV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 - 60 years
- Male or female
- Elective laparoscopic bariatric surgery
- Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h
- ASA physical-status II or III
Key exclusion criteria (16 listed)
- Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks).
- Current substance abuse or illicit drug use.
- Previous abdominal surgery within the last 6 months.
- Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists.
- Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I/III anti-arrhythmic drugs.
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 |
|---|---|---|
| Intravenous Lidocaine infusion + Standard AnesthesiaAlso: Xylocaine®, LignocaineContinuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion. | Drug | Lidocaine Infusion (LID) |
| Intravenous Dexmedetomidine infusion + Standard AnesthesiaAlso: Precedex®, Dexdor®, DEXContinuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion. | Drug | Dexmedetomidine Infusion (DEX) |
| Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard AnesthesiaAlso: LIDEX, Lidocaine-Dexmedetomidine cocktail, LID + DEXSingle syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure. | Drug | Lidocaine + Dexmedetomidine (LIDEX) |
| 0.9 % Saline Placebo + Standard AnesthesiaAlso: Normal Saline, Sodium Chloride 0.9 %, Serum Saline, 0.9 % NaClVolume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance. | Drug | Saline Placebo |
Primary outcome
Assessment of postoperative pain patient perception using the Spanish International Pain Outcomes Questionnaire (IPOQ). This questionnaire includes multiple items assessed on a numerical rating scale (NRS) from 0 to 10.
Time frame: 24 hours post-operative
* For most items (e.g., pain intensity, interference with activities, emotional impact), higher scores indicate worse outcomes. * For items such as pain relief and satisfaction, higher scores indicate better outcomes. Items include: * Highest and lowest pain intensity experienced since surgery * Proportion of time spent in pain * How pain limited physical activities (e.g., coughing, moving, walking) * Impact of pain on mood and emotional well-being * Adverse effects attributed to pain medication (e.g., nausea, dizziness) * Overall degree of pain relief obtained * Desire for additional analgesic treatment * Clarity and usefulness of information received about pain therapy * Extent of patient involvement in treatment decisions * Global satisfaction with pain management * Use of non-pharmacological methods for pain relief * Presence of pre-existing pain before hospital admission
2 secondary outcomes
Change in pro-inflammatory cytokine (IL-1β, IL-6, TNF-α) and anti -inflammatory IL-10 panel
Time frame: Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively
Change in oxidative-stress marker panel (MDA, GSH/GSSG ratio, SOD, catalase, neutrophil respiratory burst)
Time frame: Day 0 - after anesthesia induction, end of surgery, and 3 hours postoperatively
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 28 Nov 2025.
- Results publication: PubMed 39663167Xie D, Wang F, Wen W, Li H. Postoperative analgesic effect of intravenous coinjection of lidocaine and dexmedetomidine in gynaecological surgery: a systematic review and meta-analysis. BMJ Open. 2024 Dec 11;14(12):e091904. doi: 10.1136/bmjopen-2024-091904.
- Results publication: PubMed 34704710Rekatsina M, Theodosopoulou P, Staikou C. Effects of Intravenous Dexmedetomidine Versus Lidocaine on Postoperative Pain, Analgesic Consumption and Functional Recovery After Abdominal Gynecological Surgery: A Randomized Placebo-controlled Double Blind Study. Pain Physician. 2021 Nov;24(7):E997-E1006.
- Results publication: PubMed 35422388Zhang Y, Zhou Y, Hu T, Tong X, He Y, Li X, Huang L, Fu Q. Dexmedetomidine reduces postoperative pain and speeds recovery after bariatric surgery: a meta-analysis of randomized controlled trials. Surg Obes Relat Dis. 2022 Jun;18(6):846-853. doi: 10.1016/j.soard.2022.03.002. Epub 2022 Mar 9.
- Results publication: PubMed 32533519de Oliveira CMB, Coelho LMG, Valadao JA, Moura ECR, da Silva AAM, de Lima RC, Brunialti MKC, Salomao R, da Cunha Leal P, Sakata RK. Assessment of the Effect of Perioperative Venous Lidocaine on the Intensity of Pain and IL-6 Concentration After Laparoscopic Gastroplasty. Obes Surg. 2020 Oct;30(10):3912-3918. doi: 10.1007/s11695-020-04748-1. Epub 2020 Jun 12.
- Results publication: PubMed 33407156Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.
- Results publication: PubMed 37554513Lai Y, Chen Q, Xiang C, Li G, Wei K. Comparison of the Effects of Dexmedetomidine and Lidocaine on Stress Response and Postoperative Delirium of Older Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial. Clin Interv Aging. 2023 Aug 3;18:1275-1283. doi: 10.2147/CIA.S419835. eCollection 2023.
- Results publication: PubMed 38827237Chen X, Chen Q, Qin Z, Alam A, Zhao H, West R, Liu X, Li J, Li X, Yi B, Ma D, Gu J. Dexmedetomidine Attenuates Inflammation in Elderly Patients Following Major Hepatobiliary and Pancreatic Surgery: A Randomized Clinical Trial. Clin Interv Aging. 2024 May 29;19:981-991. doi: 10.2147/CIA.S455987. eCollection 2024.
- Results publication: PubMed 32778146Ohta Y, Miyamoto K, Kawazoe Y, Yamamura H, Morimoto T. Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial. Crit Care. 2020 Aug 10;24(1):493. doi: 10.1186/s13054-020-03207-8.
- Results publication: PubMed 25929655Zhang J, Wang Z, Wang Y, Zhou G, Li H. The effect of dexmedetomidine on inflammatory response of septic rats. BMC Anesthesiol. 2015 May 1;15:68. doi: 10.1186/s12871-015-0042-8.
- Results publicationAvci O, Taskiran AS, Gundogdu O. Dexmedetomidina, un agonista de α2, incrementa el efecto analgésico de la morfina y reduce el desarrollo de tolerancia a la morfina suprimiendo el estrés oxidativo y la vía de señalización de TNF/IL-1 en ratas. Rev Esp Anestesiol Reanim
- Results publication: PubMed 26903197Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
- Results publication: PubMed 32240402Kaye AD, Chernobylsky DJ, Thakur P, Siddaiah H, Kaye RJ, Eng LK, Harbell MW, Lajaunie J, Cornett EM. Dexmedetomidine in Enhanced Recovery After Surgery (ERAS) Protocols for Postoperative Pain. Curr Pain Headache Rep. 2020 Apr 2;24(5):21. doi: 10.1007/s11916-020-00853-z.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that support the results reported in this study will be shared. This includes primary outcome data (IPOPQ responses), inflammatory cytokine levels (IL-1β, IL-6, TNF-α, IL-10), oxidative stress markers (MDA, SOD, catalase, GSH/GSSG ratio), and neutrophil respiratory burst results. All data will be anonymized and coded to protect participant confidentiality.
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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.
Dulce María Rascón Martínez, Prof MD, MSc principal investigator
Instituto Mexicano del Seguro Social
Arnulfo Calixto Flores, Prof MD, PhD principal investigator
Instituto Mexicano del Seguro Social
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Lidocaine infusion + Standard Anesthesia, Intravenous Dexmedetomidine infusion + Standard Anesthesia and Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia in people with Morbid Obesity Requiring Bariatric Surgery and Postoperative Pain, run by Instituto Mexicano del Seguro Social at 2 sites 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 5 inclusion and 16 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dulce M Rascón Martínez, Prof MD, MSc (+ 52 55 5627 6900 ext. 22638, dradulcerascon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain patient perception using the Spanish International Pain Outcomes Questionnaire (IPOQ). This questionnaire includes multiple items assessed on a numerical rating scale (NRS) from 0 to 10. (time frame: 24 hours post-operative). 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 NCT07073846, which also lists 32 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 28 Nov 2025.