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

NCT06835010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-01

No results posted yet for this study

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

  • AKI - Acute Kidney Injury

Interventions

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.

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2024-11-01
Completion
2024-12-17

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835010 on ClinicalTrials.gov