NCT06928870

The Effect of Controlled Hypotension

The Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Spinal Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2). The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.

Detailed description

Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2). In the literature, various definitions of controlled hypotension exist. It is commonly defined as maintaining the Mean Arterial Pressure (MAP) between 50-65 mmHg, Systolic Arterial Pressure (SAP) between 80-90 mmHg, or reducing MAP by 30% compared to baseline values. In our study, we plan to maintain the MAP within the range of 55-75 mmHg and compare the effects of two different MAP levels on perioperative cerebral oxygen saturation, anesthetic and surgical parameters, and postoperative cognitive functions. The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.

Conditions

• Cerebral Hypoperfusion
• Hypotension

Interventions

Type	Name	Description
OTHER	MAP 55-65 mmHg	MAP will be maintained between 55-65 mmHg during anesthesia.
OTHER	MAP 66-75 mmHg	MAP will be maintained between 66-75 mmHg during anesthesia.

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-06-01
• Completion: 2025-06-30
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: Turkey (Türkiye)