Optic Nerve Sheath Diameter Clinical Trial
Official title:
Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Verified date | August 2022 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laparoscopic gastric sleeve gastrectomy is becoming an increasingly frequent procedure for patients with severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. Assessing the optic nerve sheath diameter (ONSD) with noninvasive ultrasonography has shown to be accurate in determining increased ICP as pressure changes in the subarachnoid space and the cerebrospinal fluid reflect variations in the optic nerve sheath (ONS). The investigators hypothesized that if ICP during laparoscopy is different according to the position, ONSD would likewise be different. Thus, investigators will investigate the change of ONSD according to the positional change in laparoscopic sleeve gastrectomy surgery.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | April 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients older than 18 years old undergoing laparoscopic sleeve gastrectomy under general anesthesia. Exclusion Criteria: - pre-existing neurological (e.g. hydrocephalus, intracranial hemorrhage, Etc.) Or cerebrovascular disease, past medical history of ocular pathology or surgery and the use of ketamine and/or succinylcholine during anesthesia. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tanta University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | optic nerve sheath diameter | will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum | 3 months | |
Secondary | Mean blood pressure (MBP) | will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum | 3 months | |
Secondary | Heart rate (HR) | will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum | 3 months | |
Secondary | Airway peak pressure (Ppeak) | will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum | 3 months | |
Secondary | ETCO2 | will be measured In the supine position after induction of anesthesia, 3 min after the steep anti-Trendelenburg position (35° incline), 3 min after the steep anti-Trendelenburg position combined with pneumoperitoneum, every 15 minutes and In the supine position after 3 min of de-sufflation of the pneumoperitoneum | 3 months |
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