The Effect of Controlled Hypotension (NIRS)

Ankara Etlik City Hospital

Status: Not yet enrolling

Conditions: Hypotension; Cerebral Hypoperfusion

Treatments: Other: MAP 66-75 mmHg; Other: MAP 55-65 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT06928870

AEŞH-EK1-2024-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-65 years
• ASA I-III risk group
• BMI between 18-40
• Baseline blood pressure below 140/90 mmHg
• Scheduled to undergo spinal surgery (2-4 level instrumentation)

Exclusion criteria

• Below 18 or above 65 years old
• Advanced comorbidities
• ASA IV or higher
• Baseline blood pressure above 140/90 mmHg
• History of bleeding diathesis
• Use of anticoagulant medications
• BMI below 18 or above 40
• History of previous spinal surgery

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group MAP 55-65 mmHg

Other group

Description:

Group - MAP 55-65 mmHg: MAP will be maintained between 55-65 mmHg during anesthesia.

Treatment:

Other: MAP 55-65 mmHg

Group MAP 66-75 mmHg

Other group

Description:

Group - MAP 66-75 mmHg: MAP will be maintained between 66-75 mmHg during anesthesia.

Treatment:

Other: MAP 66-75 mmHg