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NCT Number: NCT07491185

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Diabetes mellitus is associated with increased perioperative morbidity and mortality, particularly in patients with poor long-term glycemic control. Elevated HbA1c levels may impair microcirculation and tissue oxygenation, which can affect cerebral perfusion during general anesthesia. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring technique that allows continuous measurement of regional cerebral oxygen saturation and may help detect intraoperative hypoperfusion.

This prospective observational study is designed to investigate the relationship between glycemic control level and intraoperative cerebral oxygenation as well as postoperative recovery parameters in patients undergoing elective urologic surgery under general anesthesia. Patients will be divided into four groups according to preoperative HbA1c levels, including non-diabetic patients and diabetic patients with different levels of glycemic control.

Intraoperative monitoring will include standard hemodynamic parameters and bilateral regional cerebral oxygen saturation measured with near-infrared spectroscopy. The primary objective of the study is to determine whether poor glycemic control is associated with impaired cerebral oxygenation during anesthesia. Secondary objectives include evaluation of postoperative recovery parameters in relation to glycemic control level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Change in Regional Cerebral Oxygen Saturation (rSO2)

    Time frame: Intraoperative period (from anesthesia induction to extubation)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Işık Alper, Professor

CONTACT

[email protected]

+902323902140 ext. 2140

Nursen Karaca, MD

CONTACT

[email protected]

+902323902142 ext. 2142

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Effects of Intraoperative Near-Infrared Spectroscopy and Postoperative Recovery on Glycemic Control Levels in Patients With Diabetes Mellitus: A Prospective Study

Acronym: NIRS-DM

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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