Clinical trial NCT06928870: The Effect of Controlled Hypotension
Official title: The Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Hypoperfusion
Hypotension
Keywords: cerebral oxygen saturation
NIRS
controlled hypotension
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Near infrared spectroscopy (NIRS)
timeFrame: 5 minutes before induction of anesthesia
measure: Near infrared spectroscopy (NIRS)
timeFrame: 5 minutes after intubation
measure: Near infrared spectroscopy (NIRS)
timeFrame: 5 minutes after positioning prone
measure: Near infrared spectroscopy (NIRS)
timeFrame: 1 minutes after first surgical incision is made
measure: Near infrared spectroscopy (NIRS)
timeFrame: the time after one minutes target MAP value
measure: Near infrared spectroscopy (NIRS)
timeFrame: the time after ten minutes target MAP value
measure: Near infrared spectroscopy (NIRS)
timeFrame: the time after 20 minutes target MAP value
measure: Near infrared spectroscopy (NIRS)
timeFrame: 5 minutes after extubation
measure: Near infrared spectroscopy (NIRS)
timeFrame: postextubation after 15 minutes
Secondary outcomes:
measure: mini mental test
timeFrame: 15 minutes before induction of anesthesia
measure: mini mental test
timeFrame: 30 minutes after extubation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: damla usalan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.