The Effect of Controlled Hypotension (NIRS)

April 14, 2025 updated by: Damla Usalan, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Varlık Mahallesi Yenimahalle
      • Ankara, Varlık Mahallesi Yenimahalle, Turkey, 06170
        • Ankara Etlik City Hospital
        • Contact:
          • damla usalan
          • Phone Number: +903127970000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group MAP 55-65 mmHg
Group - MAP 55-65 mmHg: MAP will be maintained between 55-65 mmHg during anesthesia.
Other: MAP 55-65 mmHg
MAP will be maintained between 55-65 mmHg during anesthesia.
Other: Group MAP 66-75 mmHg
Group - MAP 66-75 mmHg: MAP will be maintained between 66-75 mmHg during anesthesia.
Other: MAP 66-75 mmHg
MAP will be maintained between 66-75 mmHg during anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near infrared spectroscopy (NIRS)
Time Frame: 5 minutes before induction of anesthesia
cerebral oxygen saturation
5 minutes before induction of anesthesia
Near infrared spectroscopy (NIRS)
Time Frame: 5 minutes after intubation
cerebral oxygen saturation
5 minutes after intubation
Near infrared spectroscopy (NIRS)
Time Frame: 5 minutes after positioning prone
cerebral oxygen saturation
5 minutes after positioning prone
Near infrared spectroscopy (NIRS)
Time Frame: 1 minutes after first surgical incision is made
cerebral oxygen saturation
1 minutes after first surgical incision is made
Near infrared spectroscopy (NIRS)
Time Frame: the time after one minutes target MAP value
cerebral oxygen saturation
the time after one minutes target MAP value
Near infrared spectroscopy (NIRS)
Time Frame: the time after ten minutes target MAP value
cerebral oxygen saturation
the time after ten minutes target MAP value
Near infrared spectroscopy (NIRS)
Time Frame: the time after 20 minutes target MAP value
cerebral oxygen saturation
the time after 20 minutes target MAP value
Near infrared spectroscopy (NIRS)
Time Frame: 5 minutes after extubation
cerebral oxygen saturation
5 minutes after extubation
Near infrared spectroscopy (NIRS)
Time Frame: postextubation after 15 minutes
cerebral oxygen saturation
postextubation after 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini mental test
Time Frame: 15 minutes before induction of anesthesia
It is used to evaluate cognitive function.
15 minutes before induction of anesthesia
mini mental test
Time Frame: 30 minutes after extubation
It is used to evaluate cognitive function.
30 minutes after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Investigators

  • Principal Investigator: damla usalan, Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK1-2024-0003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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