The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Prone Position
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedMay 26, 2022
May 1, 2022
6 months
May 23, 2022
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebral tissue oxygen saturation with NIRS .Effect os boddy mass index on cerebral tissue oxygen saturation in prone position
Effects of boddy mass index and intraabdominal pressure on cerebral tissue oxygen saturation in prone position
İntraoperatif ( During surgery)
Eligibility Criteria
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
You may qualify if:
- Age 18-70 years
- ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Özlem Şen
Trabzon Kanuni Training and Research Hospital
- STUDY CHAIR
Dilek Kalaycı
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
- STUDY CHAIR
Süheyla Ünver
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
- STUDY CHAIR
Tülay Dal
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
- STUDY CHAIR
Kübra Kutay
Bağcılar Training and Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 23, 2022
First Posted
May 26, 2022
Study Start
March 10, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
May 26, 2022
Record last verified: 2022-05