Clinical trial NCT05392478: The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Prone Position
Official title: The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Lumbar Spine Surgery İn Prone Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Hypoxia During and/or Resulting From A Procedure
Keywords: cerebral oxygenation, prone position, obesity
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels. The ethical committee approval for the study was taken from the Abdurrahman Yurtaslan Oncology Training and Research Hospital (2014-2182). The informed consent was obtained for all the patients that were included in the study

Brief summary: A total of 40 ASA (American Society of Anesthesiology) physical status I-III who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. A standard anesthesia protocol was performed in all patients. Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Patients' demographics such as age, gender, height, weight, BMI, smoking status and pre-existing medical conditions were recorded.The patients were allocated equally to two groups according to BMI as Group I: BMI ≥30kg/m2,Group II \<30 kg/m2.

Detailed description: Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Frontal lobe oxygenation was monitored continuously and recorded every 5 minutes.Before positioning patients on the operating table, a Foley catheter was placed. IAP was measured in the following positions in all patients: 1) in the supine position after intubation 2) in the prone position before the skin incision.All patients were placed into the prone position on the silicone pads after general anesthesia.Before statistical analysis, the 40 patients were allocated equally to two groups according to the World Health Organization Guideline of BMI: Group I: BMI ≥30kg/m2, Group II \<30 kg/m2

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels

Exclusion Criteria:

* Age smaller than 18 or older than 70 years,
* ASA physical status more than III,
* Patients with a history of carotid artery stenosis, prior neck surgery, cervical canal stenosis, stroke, neurological deficit, myocardial infarction, spinal cord injury and sudden vision loss

Primary outcomes:
measure: Cerebral tissue oxygen saturation with NIRS .Effect os boddy mass index on cerebral tissue oxygen saturation in prone position
timeFrame: İntraoperatif ( During surgery)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Trabzon Kanuni Training and Research Hospital
name: Özlem Şen
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
name: Dilek Kalaycı
role: STUDY_CHAIR
affiliation: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
name: Süheyla Ünver
role: STUDY_CHAIR
affiliation: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
name: Tülay Dal
role: STUDY_CHAIR
affiliation: Bağcılar Training and Research Hospital
name: Kübra Kutay
role: STUDY_CHAIR
References: