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NCT Number: NCT06928870

The Effect of Controlled Hypotension

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi Yenimahalle, 06170, Turkey (Türkiye)

Location contact

damla usalan

CONTACT

+903127970000

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MAP 55-65 mmHg

Other

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

MAP 66-75 mmHg

Other

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

Primary outcomes

  1. Near infrared spectroscopy (NIRS)

    Time frame: 5 minutes before induction of anesthesia

    cerebral oxygen saturation

  2. Near infrared spectroscopy (NIRS)

    Time frame: 5 minutes after intubation

    cerebral oxygen saturation

  3. Near infrared spectroscopy (NIRS)

    Time frame: 5 minutes after positioning prone

    cerebral oxygen saturation

  4. Near infrared spectroscopy (NIRS)

    Time frame: 1 minutes after first surgical incision is made

    cerebral oxygen saturation

  5. Near infrared spectroscopy (NIRS)

    Time frame: the time after one minutes target MAP value

    cerebral oxygen saturation

  6. Near infrared spectroscopy (NIRS)

    Time frame: the time after ten minutes target MAP value

    cerebral oxygen saturation

  7. Near infrared spectroscopy (NIRS)

    Time frame: the time after 20 minutes target MAP value

    cerebral oxygen saturation

  8. Near infrared spectroscopy (NIRS)

    Time frame: 5 minutes after extubation

    cerebral oxygen saturation

  9. Near infrared spectroscopy (NIRS)

    Time frame: postextubation after 15 minutes

    cerebral oxygen saturation

Secondary outcomes

  1. mini mental test

    Time frame: 15 minutes before induction of anesthesia

    It is used to evaluate cognitive function.

  2. mini mental test

    Time frame: 30 minutes after extubation

    It is used to evaluate cognitive function.

Study contacts

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

damla usalan

CONTACT

[email protected]

+905059181063

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Acronym: NIRS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

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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