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Acute Kidney InjuryNCT07094165

The Effects of Dexmedetomidine and Remifentanil on Kidney Injury After Muscle Compression Injury in Rats

A study testing Dexmedetomidine, Remifentanil and Laparotomy in people with Acute Kidney Injury and Crush Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this interventional preclinical study is to evaluate the potential protective effects of two intravenous anesthetic agents-dexmedetomidine and remifentanil-on kidney function in the context of muscle crush injury, which is known to be a major contributor to acute kidney injury (AKI) following trauma… Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Kidney Injury, Crush Injury, Rhabdomyolysis
What is being tested?
Dexmedetomidine, Remifentanil and Laparotomy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jul 2024to 10 Mar 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Rat Experiment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Remifentanil and Dexmedetomidine on Crush Injury and Renal Functions in an Experimental Model

The goal of this interventional preclinical study is to evaluate the potential protective effects of two intravenous anesthetic agents-dexmedetomidine and remifentanil-on kidney function in the context of muscle crush injury, which is known to be a major contributor to acute kidney injury (AKI) following trauma, entrapment, or disasters such as earthquakes. AKI following crush syndrome results from rhabdomyolysis, hypovolemia, oxidative stress, and systemic inflammation, and it significantly increases morbidity and mortality. This study explores whether anesthetic choice during the acute phase of injury influences renal outcomes.

This study used a rat model of crush injury. A total of 28 healthy adult male Wistar rats were randomly divided into four groups (n=7 per group):

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  1. Control group - no surgical procedure, no injury, no drug.
  2. Sham group - anesthesia and cannulation were performed but no crush injury or drug administered.
  3. Dexmedetomidine group - crush injury + intravenous dexmedetomidine infusion (3 µg/kg/h) for 1 hour.
  4. Remifentanil group - crush injury + intravenous remifentanil infusion (1 µg/kg/h) for 1 hour.

Crush injury was induced by applying a metal clamp with a constant pressure of 3 kg to both gastrocnemius muscles for 2 hours, under anesthesia. After the clamp was removed, animals in the two treatment groups received a one-hour intravenous infusion of their assigned drug. Blood samples were taken at baseline and at 6 hours post-injury. After euthanasia, bilateral kidney tissues were harvested for biochemical and histopathological evaluation.

The main questions this study aimed to answer were:

  • Does dexmedetomidine reduce serum and tissue levels of AKI biomarkers (such as NGAL, KIM-1, TIMP-2, IGFBP7) more effectively than remifentanil in a rat model of crush injury?
  • Are there histological differences in kidney damage between the treatment groups?
  • What is the impact of both drugs on oxidative stress markers (TAC - total antioxidant capacity, TOS - total oxidant status) and renal function parameters such as creatinine and urea?

Biochemical analyses included ELISA-based quantification of NGAL, KIM-1, TIMP-2, IGFBP7, TAC, TOS, serum creatinine, and BUN. Histopathological scoring was performed by a blinded pathologist, assessing tubular necrosis, interstitial edema, and inflammatory cell infiltration.

The study found that rats in the dexmedetomidine group exhibited lower levels of renal injury markers and histopathological damage scores compared to those in the remifentanil group. These findings suggest that dexmedetomidine may offer superior renal protection during acute crush injury compared to remifentanil, potentially via anti-inflammatory and antioxidant mechanisms.

The results of this study may help guide anesthetic drug selection in trauma patients at high risk of kidney injury, and lay the foundation for future translational research.

Being tested
Dexmedetomidine, Remifentanil, Laparotomy, Compression
Keywords
remifentanil, dexmedetomidine, crush injury, renal injury, KIM-1, NGAL
Medical subject headings
Acute Kidney Injury, Crush Injuries, Rhabdomyolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Following 2 hours of bilateral muscle compression, rats in the dexmedetomidine group underwent a 1-hour period including both laparotomy and continuous intravenous dexmedetomidine infusion.

  • RemifentanilDrug

    Following 2 hours of bilateral muscle compression, rats in the remifentanil group underwent a 1-hour period including both laparotomy and continuous intravenous remifentanil infusion.

  • LaparotomyProcedure or surgery

    A standardized laparotomy was carried out for 1 hour, during which the abdominal cavity was opened and subsequently closed. This procedure aimed to mimic the physiological impact of a one-hour surgical operation.

  • CompressionProcedure or surgery

    Bilateral compression was applied to the gastrocnemius muscles for a duration of 2 hours.

Study groups in NCT07094165
Study groupRoleWhat they receive
ControlNo interventionThe control group did not receive any intervention or pharmacological treatment.
DexmedetomidineExperimentalFollowing 2 hours of bilateral muscle compression, rats in the dexmedetomidine group underwent a 1-hour period including both laparotomy and continuous intravenous dexmedetomidine infusion.
Receives: Drug: Dexmedetomidine; Procedure: Laparotomy; Procedure: Compression
RemifentanilExperimentalFollowing 2 hours of bilateral muscle compression, rats in the remifentanil group underwent a 1-hour period including both laparotomy and continuous intravenous remifentanil infusion.
Receives: Drug: Remifentanil; Procedure: Laparotomy; Procedure: Compression
ShamSham comparatorIn the sham group, bilateral gastrocnemius muscle compression was applied for 2 hours and laparotomy was performed, but no pharmacological intervention was given.
Receives: Procedure: Laparotomy; Procedure: Compression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Creatinine Level

    Change in serum creatinine levels measured at 0, 2, and 6 hours after experimental crush injury in Wistar Albino rats receiving either dexmedetomidine or remifentanil. This outcome is used to assess renal function and the nephroprotective effect of the interventions.

    Measured: Baseline (0 hour), 2 hours, and 6 hours after intervention

Secondary outcomes (4)
  1. Neutrophil Gelatinase-Associated Lipocalin (NGAL) Level

    NGAL levels measured in serum at three time points to assess early renal tubular injury following experimental crush injury and treatment with dexmedetomidine or remifentanil. NGAL is an early biomarker for acute kidney injury (AKI) and reflects renal stress.

    Measured: 0, 2, and 6 hours after intervention

  2. Histopathological Tubular Injury Score

    Histopathological evaluation of renal tissue samples using scoring for tubular necrosis, brush border loss, dilatation, congestion, and apoptotic cell count. Quantitative damage scoring was performed blindly by two pathologists to compare the nephroprotective effects of dexmedetomidine and remifentanil.

    Measured: At 6 hours after intervention (after sacrifice)

  3. Kidney Injury Molecule-1 (KIM-1) Level

    Serum levels of KIM-1 measured by ELISA to evaluate renal tubular epithelial injury and compare the protective effects of the two anesthetic agents.

    Measured: 0, 2, and 6 hours after intervention

  4. TIMP-2) × (IGFBP7) Product Level

    0, 2, and 6 hours after intervention

    Measured: The combined serum levels of TIMP-2 and IGFBP7, representing G1 cell cycle arrest, were measured to detect early renal stress and predict AKI development in the experimental model.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start10 Jul 2024
  3. Primary completion7 Mar 2025
  4. Study completion10 Mar 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094165
Sponsor's protocol ID
AnkaraCHBilkent0741
Status last verified
Jul 2025
First submitted
23 Jul 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a preclinical animal study conducted on Wistar Albino rats. Since no human subjects were enrolled, there is no individual participant data (IPD) to share.

Publications

  • Bao N, Dai D. Dexmedetomidine Protects against Ischemia and Reperfusion-Induced Kidney Injury in Rats. Mediators Inflamm. 2020 Apr 3;2020:2120971. doi: 10.1155/2020/2120971. eCollection 2020.

    PubMed 32317860
  • Bywaters EG, Beall D. Crush Injuries with Impairment of Renal Function. Br Med J. 1941 Mar 22;1(4185):427-32. doi: 10.1136/bmj.1.4185.427. No abstract available.

    PubMed 20783577
  • Bostankolu E, Ayoglu H, Yurtlu S, Okyay RD, Erdogan G, Deniz Y, Hanci V, Can M, Turan IO. Dexmedetomidine did not reduce the effects of tourniquet-induced ischemia-reperfusion injury during general anesthesia. Kaohsiung J Med Sci. 2013 Feb;29(2):75-81. doi: 10.1016/j.kjms.2012.08.013. Epub 2012 Oct 13.

    PubMed 23347808
  • Celikmen MF, Sarikaya S, Ozucelik DN, Sever MS, Aciksari K, Celikmen DM, Yazicioglu M, Kandemir A, Dogan H, Ayvaci BM, Ozasir Abuska D, Sadillioglu S. Effects of acetaminophen and mannitol on crush injuries in rats: An experimental study. Ulus Travma Acil Cerrahi Derg. 2016 Jul;22(4):305-14. doi: 10.5505/tjtes.2015.76824.

    PubMed 27598600
  • de Carvalho AL, Vital RB, Kakuda CM, Braz JR, Castiglia YM, Braz LG, Modolo MP, Ribeiro OR, Domingues MA, Modolo NS. Dexmedetomidine on renal ischemia-reperfusion injury in rats: assessment by means of NGAL and histology. Ren Fail. 2015 Apr;37(3):526-30. doi: 10.3109/0886022X.2015.1006118. Epub 2015 Jan 23.

    PubMed 25613736
  • Erkilic E, Kesimci E, Alaybeyoglu F, Kilinc I, Tural R, Yazgan A, Gumus T, Sepici Dincel A, Dumlu EG, Kanbak O. Does remifentanil attenuate renal ischemia-reperfusion injury better than dexmedetomidine in rat kidney? Drug Des Devel Ther. 2017 Mar 8;11:677-683. doi: 10.2147/DDDT.S126701. eCollection 2017.

    PubMed 28331287
  • Gonullu E, Ozkardesler S, Kume T, Duru LS, Akan M, Guneli ME, Ergur BU, Meseri R, Dora O. Comparison of the effects of dexmedetomidine administered at two different times on renal ischemia/reperfusion injury in rats. Braz J Anesthesiol. 2014 May-Jun;64(3):152-8. doi: 10.1016/j.bjane.2013.06.002. Epub 2013 Oct 16.

    PubMed 24907872
  • Kanbak O, Aydogan B, Gumus T. Effects of remifentanil and propofol on distant organ lung injury in an ischemia-reperfusion model. Open Med (Wars). 2021 Nov 8;16(1):1673-1680. doi: 10.1515/med-2021-0381. eCollection 2021.

    PubMed 34761118
  • Kocoglu H, Ozturk H, Ozturk H, Yilmaz F, Gulcu N. Effect of dexmedetomidine on ischemia-reperfusion injury in rat kidney: a histopathologic study. Ren Fail. 2009;31(1):70-4. doi: 10.1080/08860220802546487.

    PubMed 19142813
  • Sugita S, Okabe T, Sakamoto A. Continuous infusion of dexmedetomidine improves renal ischemia-reperfusion injury in rat kidney. J Nippon Med Sch. 2013;80(2):131-9. doi: 10.1272/jnms.80.131.

    PubMed 23657066
  • Si YN, Bao HG, Xu L, Wang XL, Shen Y, Wang JS, Yang XB. Dexmedetomidine protects against ischemia/reperfusion injury in rat kidney. Eur Rev Med Pharmacol Sci. 2014 Jul;18(13):1843-51.

    PubMed 25010612

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine, Remifentanil and Laparotomy in people with Acute Kidney Injury and Crush Injury, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 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 Turkey (Türkiye). 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.

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?

Serum Creatinine Level (time frame: Baseline (0 hour), 2 hours, and 6 hours after intervention). 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 NCT07094165, which also lists 11 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 30 Jul 2025.

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