NCT06928870

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

February 7, 2025

Last Update Submit

April 14, 2025

Conditions

Cerebral HypoperfusionHypotension

Keywords

cerebral oxygen saturationNIRScontrolled hypotension

Outcome Measures

Primary Outcomes (9)

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    5 minutes before induction of anesthesia

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    5 minutes after intubation

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    5 minutes after positioning prone

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    1 minutes after first surgical incision is made

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    the time after one minutes target MAP value

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    the time after ten minutes target MAP value

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    the time after 20 minutes target MAP value

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    5 minutes after extubation

  • Near infrared spectroscopy (NIRS)

    cerebral oxygen saturation

    postextubation after 15 minutes

Secondary Outcomes (2)

  • mini mental test

    15 minutes before induction of anesthesia

  • mini mental test

    30 minutes after extubation

Study Arms (2)

Group MAP 55-65 mmHg

OTHER

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

Other: MAP 55-65 mmHg

Group MAP 66-75 mmHg

OTHER

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

Other: MAP 66-75 mmHg

Interventions

MAP 55-65 mmHgOTHER

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

Group MAP 55-65 mmHg
MAP 66-75 mmHgOTHER

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

Group MAP 66-75 mmHg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

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

Location

Related Publications (2)

  • Dutton RP. Controlled hypotension for spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S66-71. doi: 10.1007/s00586-004-0756-7. Epub 2004 Jun 9.

    PMID: 15197633BACKGROUND

  • Ooms M, Schooss R, Winnand P, Heitzer M, Holzle F, Bickenbach J, Rieg A, Modabber A. Influence of perioperative blood pressure regulation on postoperative delirium in patients undergoing head and neck free flap reconstruction. Eur J Med Res. 2023 Sep 22;28(1):365. doi: 10.1186/s40001-023-01367-1.

    PMID: 37736691RESULT

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • damla usalan

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

damla usalan

CONTACT

+905059181063dusalan78@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2025

First Posted

April 15, 2025

Study Start

April 30, 2025

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations

TU(1)