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

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.

Study Overview

• Status: Completed
• Conditions: AKI - Acute Kidney Injury
• Intervention / Treatment: Drug: Sevoflurane inhalant product; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 13511
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who were assigned for TKR surgery;
• Patients with preoperative serum creatinine (SCr) levels of <1.1 mg/ml;
• Patients with controlled medical conditions;
• Patients free of exclusion criteria were enrolled in the study.

Exclusion Criteria:

• Male patients were excluded to guard against the impact of senile prostatic hypertrophy on kidney functions;
• Patients who had preoperative SCr of >1.1 mg/dl;
• Presence of any urological disorders, urological stone diseases;
• Patients with autoimmune diseases, medical disorders requiring maintenance on immunosuppressant therapy;
• Patients with cancer anywhere in the body were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SEVO Group	Drug: Sevoflurane inhalant product; Anesthesia 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.
Active Comparator: DXM Group	Drug: Sevoflurane inhalant product; Anesthesia 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.; Drug: Dexmedetomidine; Dexmedetomidine (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Difference in Serum Creatinine levels After Dexmedetomidine Administration in Total Knee Replacement surgery under sevoflurane anesthesia.	The study assesses the mean percentage difference of serum creatinine levels in patients who was undergoing total knee replacement under sevoflurane anesthesia with Dexmedetomidine infusion (using standard laboratory assays).	5 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: February 9, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 36264PR666/4/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No