NCT07073846|RecruitingPhase 4DMC

Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.

Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery

Instituto Mexicano del Seguro Social ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

R-2025-3601-197

Study Type

interventional

Estimated enrollment

104

Locations

1 country

Sites

Timeline

Study Start

October 6, 2025

Actual (reported)

Primary Completion

May 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

July 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 104 participants
Study completion date: July 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 30, 2025
Actual (reported)
First Posted
July 18, 2025
Actual (reported)
Study Start
October 6, 2025
Actual (reported)
Primary Completion
May 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: November 28, 2025
Status Verified: November 2025
Last Update Submitted: November 26, 2025

Conditions

Morbid Obesity Requiring Bariatric Surgery Postoperative Adjuvant Treatment Postoperative Analgesia Postoperative Inflammatory Markers Postoperative Inflammatory Response

Related Publications (32)

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.

PMID: 39663167RESULT

Rekatsina 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.

PMID: 34704710RESULT

Zhang 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.

PMID: 35422388RESULT

de 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.

PMID: 32533519RESULT

Xu 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.

PMID: 33407156RESULT

Lai 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.

PMID: 37554513RESULT

Chen 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.

PMID: 38827237RESULT

Ohta 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.

PMID: 32778146RESULT

Zhang 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.

PMID: 25929655RESULT

Avci 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

RESULT

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.

PMID: 26903197RESULT

Kaye 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.

PMID: 32240402RESULT

Lai 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.

PMID: 38085848RESULT

Jessen 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.

PMID: 26889627RESULT

Lin 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.

PMID: 31958741RESULT

Lee JM, Suh JK, Jeong JS, Cho SY, Kim DW. Antioxidant effect of lidocaine and procaine on reactive oxygen species-induced endothelial dysfunction in the rabbit abdominal aorta. Korean J Anesthesiol. 2010 Aug;59(2):104-10. doi: 10.4097/kjae.2010.59.2.104. Epub 2010 Aug 20.

PMID: 20740215RESULT

Gunaydin B, Demiryurek AT. Interaction of lidocaine with reactive oxygen and nitrogen species. Eur J Anaesthesiol. 2001 Dec;18(12):816-22. doi: 10.1046/j.1365-2346.2001.00931.x.

PMID: 11737181RESULT

Castro I, Carvalho P, Vale N, Monjardino T, Mourao J. Systemic Anti-Inflammatory Effects of Intravenous Lidocaine in Surgical Patients: A Systematic Review and Meta-Analysis. J Clin Med. 2023 May 31;12(11):3772. doi: 10.3390/jcm12113772.

PMID: 37297968RESULT

Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.

PMID: 30117019RESULT

MacGregor RR, Thorner RE, Wright DM. Lidocaine inhibits granulocyte adherence and prevents granulocyte delivery to inflammatory sites. Blood. 1980 Aug;56(2):203-9. No abstract available.

PMID: 7397378RESULT

Paterson HM, Cotton S, Norrie J, Nimmo S, Foo I, Balfour A, Speake D, MacLennan G, Stoddart A, Innes K, Cameron S, Aucott L, McCormack K. The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery. Trials. 2022 Jan 28;23(1):84. doi: 10.1186/s13063-022-06021-5.

PMID: 35090535RESULT

Ahn E, Kang H, Choi GJ, Park YH, Yang SY, Kim BG, Choi SW. Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study. Int Surg. 2015 Mar;100(3):394-401. doi: 10.9738/INTSURG-D-14-00225.1.

PMID: 25785316RESULT

Eipe N, Gupta S, Penning J. Intravenous lidocaine for acute pain: an evidence-based clinical update. BJA Educ. 2016 Sep 1;16(9):292-8.

RESULT

Baysal Z, Togrul T, Aksoy N, Cengiz M, Celik H, Boleken ME, Kaya M, Yavuz G. Evaluation of total oxidative and antioxidative status in pediatric patients undergoing laparoscopic surgery. J Pediatr Surg. 2009 Jul;44(7):1367-70. doi: 10.1016/j.jpedsurg.2008.11.031.

PMID: 19573663RESULT

Tsuchiya M, Sato EF, Inoue M, Asada A. Open abdominal surgery increases intraoperative oxidative stress: can it be prevented? Anesth Analg. 2008 Dec;107(6):1946-52. doi: 10.1213/ane.0b013e318187c96b.

PMID: 19020142RESULT

Mieszczanski P, Gorniewski G, Ziemianski P, Cylke R, Lisik W, Trzebicki J. Comparison between multimodal and intraoperative opioid free anesthesia for laparoscopic sleeve gastrectomy: a prospective, randomized study. Sci Rep. 2023 Aug 4;13(1):12677. doi: 10.1038/s41598-023-39856-2.

PMID: 37542100RESULT

Ivascu R, Torsin LI, Hostiuc L, Nitipir C, Corneci D, Dutu M. The Surgical Stress Response and Anesthesia: A Narrative Review. J Clin Med. 2024 May 20;13(10):3017. doi: 10.3390/jcm13103017.

PMID: 38792558RESULT

Torensma B, Hany M, Bakker MJS, van Velzen M, In 't Veld BA, Dahan A, Swank DJ. Correction to: Cross-Sectional E-survey on the Incidence of Pre- and Postoperative Chronic Pain in Bariatric Surgery. Obes Surg. 2023 Jan;33(1):211. doi: 10.1007/s11695-022-06395-0. No abstract available.

PMID: 36463344RESULT

Iamaroon A, Tangwiwat S, Nivatpumin P, Lertwacha T, Rungmongkolsab P, Pangthipampai P. Risk Factors for Moderate to Severe Pain during the First 24 Hours after Laparoscopic Bariatric Surgery While Receiving Intravenous Patient-Controlled Analgesia. Anesthesiol Res Pract. 2019 Oct 3;2019:6593736. doi: 10.1155/2019/6593736. eCollection 2019.

PMID: 31687018RESULT

Garduno-Lopez AL, Acosta Nava VM, Castro Garces L, Rascon-Martinez DM, Cuellar-Guzman LF, Flores-Villanueva ME, Villegas-Sotelo E, Carrillo-Torres O, Vilchis-Samano H, Calderon-Vidal M, Islas-Lagunas G, Richard Chapman C, Komann M, Meissner W, Baumbach P, Zaslansky R. Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT. J Pain Res. 2021 Feb 15;14:415-430. doi: 10.2147/JPR.S282850. eCollection 2021.

PMID: 33623424RESULT

De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.

PMID: 24036842RESULT

Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.

PMID: 18499604RESULT

Study Design

Study Type

interventional

Phase

phase 4

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

Randomisation codes are generated in 13 permuted blocks of eight by an independent investigator who is not involved in patient care or outcome assessment. The codes are printed, placed in sequentially numbered, opaque, sealed envelopes, and handed to the study nursing team. Immediately before anaesthetic induction, a research nurse opens the next envelope and communicates the allocation to a second nurse-preparer (also independent from clinical care). This nurse draws up a visually identical 50 mL syringe containing lidocaine, dexmedetomidine, the fixed-dose combination (LIDEX), or 0.9 % saline, according to the code. Each syringe is labelled only with the participant ID and infusion rate. Emergency unblinding is allowed solely for patient-safety reasons and must be reported immediately to the Data and Safety Monitoring Board.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Randomized, quadruple-masked, four-arm parallel design.

Sponsor Type

OTHER GOV

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Clinical Research Physician

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 18, 2025

Study Start

October 6, 2025

Actual (reported)

Primary Completion

May 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

July 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing

Will share

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.

Shared Documents

STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Time Frame

IPD will be available beginning 6 months after publication of the main study results in a peer-reviewed journal, and will remain available for up to 5 years after publication.

Access Criteria

The de-identified individual participant data (IPD) that support the results of this study will be available to any interested researchers. The data will be publicly accessible through an open-access Zenodo repository following publication of the main study results. No request or approval will be necessary. All data will be anonymized and will not contain any information that could identify participants. Supporting documents such as the protocol, statistical analysis plan, and informed consent form will also be available in the same repository.

More information

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier

NCT07073846

Data provider

ClinicalTrials.gov

Source updated

2025-11-28

Normalization version

ctgov-legacy-1

Source retrieved: 2026-10-25 22:22:02 UTC

Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Lidocaine Infusion (LID)

Dexmedetomidine Infusion (DEX)

Lidocaine + Dexmedetomidine (LIDEX)

Saline Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (32)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Lidocaine Infusion (LID)

Dexmedetomidine Infusion (DEX)

Lidocaine + Dexmedetomidine (LIDEX)

Saline Placebo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (32)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations