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

NCT06835010 | Completed

• 1 other identifier: 36264PR666/4/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SEVO Group

ACTIVE COMPARATOR

Drug: Sevoflurane inhalant product

DXM Group

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Sevoflurane inhalant product

Interventions

Dexmedetomidine DRUG

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.

DXM Group

Sevoflurane inhalant product DRUG

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.

DXM Group; SEVO Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were assigned for TKR surgery;
• Patients with preoperative serum creatinine (SCr) levels of \<1.1 mg/ml;
• Patients with controlled medical conditions;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 19, 2025
• Study Start: May 20, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 17, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

EG (1)