NCT05392478

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

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

March 10, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

cerebral oxygenation, prone position, obesity

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

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özlem Şen

    Trabzon Kanuni Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

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