The Effect of Controlled Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MAP 55-65 mmHg, MAP 66-75 mmHg.
- Who it may be relevant to
- Registry conditions: Cerebral Hypoperfusion, Hypotension. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Spinal Surgery
Overview
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.
Interventions
- Other MAP 55-65 mmHg
MAP will be maintained between 55-65 mmHg during anesthesia. - Other MAP 66-75 mmHg
MAP will be maintained between 66-75 mmHg during anesthesia.
Primary outcome measures
- Near infrared spectroscopy (NIRS) [Time frame: 5 minutes before induction of anesthesia]
- Near infrared spectroscopy (NIRS) [Time frame: 5 minutes after intubation]
- Near infrared spectroscopy (NIRS) [Time frame: 5 minutes after positioning prone]
- Near infrared spectroscopy (NIRS) [Time frame: 1 minutes after first surgical incision is made]
- Near infrared spectroscopy (NIRS) [Time frame: the time after one minutes target MAP value]
- Near infrared spectroscopy (NIRS) [Time frame: the time after ten minutes target MAP value]
- Near infrared spectroscopy (NIRS) [Time frame: the time after 20 minutes target MAP value]
- Near infrared spectroscopy (NIRS) [Time frame: 5 minutes after extubation]
- Near infrared spectroscopy (NIRS) [Time frame: postextubation after 15 minutes]
Secondary outcome measures (2)
- mini mental test [Time frame: 15 minutes before induction of anesthesia]
- mini mental test [Time frame: 30 minutes after extubation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Ankara Etlik City Hospital — Ankara
Publications
- 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 15197633
- 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 37736691
Identifiers
NCT: NCT06928870 · AEŞH-EK1-2024-0003