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Trials / Completed

CompletedNCT06835010

Sevoflurane and Dexmedetomidine's Contrasting Renal Impacts After Non-Cardiac Surgery

Contradictory Effect of Sevoflurane and Dexmedetomidine on Kidney Function After Non-Cardiac Surgical Procedures Possibly Through Immunomodulation and Adjustment of Redox Milieu

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Tanta University · Academic / Other
Sex
Female
Age
45 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Postoperative acute kidney injury (PO-AKI) is a significant complication, especially after complex surgeries. The choice of anesthetic may influence PO-AKI risk. While sevoflurane (SEVO) has been associated with potential renal risks, dexmedetomidine (DXM) has demonstrated renoprotective effects in various surgical settings. These protective effects may be linked to DXM's immunomodulatory properties and influence on the redox balance. Given the common use of SEVO in major non-cardiac surgery and the potential for renal vulnerability, particularly in the elderly, this study hypothesizes that perioperative DXM infusion in patients undergoing major non-cardiac surgery with SEVO anesthesia will reduce the incidence and severity of PO-AKI, especially in those with pre-existing or borderline renal dysfunction.

Conditions

Interventions

TypeNameDescription
DRUGDexmedetomidineDexmedetomidine (Precedex, 100 µg/ml; Rewine Pharmaceutical; Varachha, Seurat, Gujarat) was administered before induction of anesthesia in the form of a 1 µg/kg; loading dose. The loading dose was diluted with 10 ml of normal saline and injected slowly for 10 minutes. IO infusion was prepared to provide 0.2-0.7 µg/kg/h, initially the lowest possible dose was infused and was increased gradually to control IO stress reflexes but with MAP, and HR monitoring to guard against IO hypotension and bradycardia. PO infusion was prepared to provide DXM in a dose of 0.15 µg/kg/h for 24-h. Placebo 0.9% saline solution was provided to patients of the SEVO group at a similar rate and duration.
DRUGSevoflurane inhalant productAnesthesia was induced by fentanyl 1 μg/kg/min, propofol 1.5-2 mg/kg and rocuronium 0.5 mg/kg, then tracheal intubation was aided by gentle tracheal pressure and an endotracheal tube of appropriate size was inserted with the aid of fiberoptic laryngoscopy and patients were mechanically ventilated to keep ETCO2 in the range of 30-35 mmHg. Anesthesia was maintained for patients of both groups by sevoflurane 2% in oxygen 100% and rocuronium (0.15 mg/ kg) according to the requirements.

Timeline

Start date
2024-05-20
Primary completion
2024-11-01
Completion
2024-12-17
First posted
2025-02-19
Last updated
2025-12-01

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06835010. Inclusion in this directory is not an endorsement.