The Effect of Controlled Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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

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Cerebral Hypoperfusion Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group MAP 55-65 mmHg

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

Group Type OTHER

MAP 55-65 mmHg

Intervention Type OTHER

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

Group MAP 66-75 mmHg

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

Group Type OTHER

MAP 66-75 mmHg

Intervention Type OTHER

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

Interventions

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MAP 55-65 mmHg

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

Intervention Type OTHER

MAP 66-75 mmHg

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No