Effect of Glycemic Control on Intraoperative NIRS and Postoperative Recovery in Diabetic Patients

NCT07491185 | Recruiting

• 1 other identifier: 25-10.2T/45
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the effect of glycemic control level on intraoperative cerebral oxygenation measured by near-infrared spectroscopy (NIRS) and postoperative recovery in patients with diabetes mellitus undergoing elective urologic surgery under general anesthesia. Patients will be grouped according to HbA1c levels to assess the relationship between long-term glycemic control and intraoperative regional cerebral oxygen saturation, hemodynamic parameters, and postoperative recovery scores.

Conditions

Diabetes Mellitus; Glycemic Control; Cerebral Oxygenation; Anesthesia

Keywords

Diabetes Mellitus; Glycemic Control; Near-Infrared Spectroscopy; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Change in Regional Cerebral Oxygen Saturation (rSO2)

  Regional cerebral oxygen saturation measured intraoperatively using near-infrared spectroscopy and compared between groups according to HbA1c level.

  Intraoperative period (from anesthesia induction to extubation)

Study Arms (4)

Control

Non-diabetic patients

HbA1c 6-7

Diabetic patients with HbA1c between 6% and 7%

HbA1c 7-8

Diabetic patients with HbA1c between 7% and 8%

HbA1c >8

Diabetic patients with HbA1c greater than 8%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective urologic surgery under general anesthesia at a single tertiary university hospital will be included. The study population consists of patients with diabetes mellitus with different levels of glycemic control and non-diabetic control patients. Participants will be grouped according to preoperative HbA1c levels.

You may qualify if:

• Age ≥18 years
• Patients scheduled for elective urologic surgery under general anesthesia
• ASA physical status I-III
• Patients with diabetes mellitus or non-diabetic control patients
• Availability of preoperative HbA1c measurement
• Written informed consent obtained

You may not qualify if:

• Age \<18 years
• ASA physical status \>III
• Emergency surgery
• History of cerebrovascular disease or neurological disorder
• Previous brain or neurological surgery
• Inability to communicate or refusal to participate
• Intraoperative hemodynamic instability
• Inadequate NIRS monitoring data

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine Hospital

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• NURSEN KARACA, MD

  Ege University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nursen Karaca, MD

CONTACT

+902323902142; dr.nursenkaraca@hotmail.com

Işık Alper, Professor

CONTACT

+902323902140; i.alper@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)