Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05485363
Collaborator
(none)
20
1
7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasonographic measurement of the optic nerve sheath diameter
N/A

Detailed Description

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.

The impacts of laparoscopy on the intracranial pressure (ICP) are well-documented and several studies have demonstrated that the induction of artificial pneumoperitoneum provokes a measurable increase in ICP. The mechanisms of increase of ICP during laparoscopy are suggested as follows: increase of intra-abdominal pressure, impairment of cerebrospinal fluid (CSF) absorption and impeded drainage of the lumbar venous plexus, increased pressure in the vascular compartment of sacral spaces, Trendelenburg position, and cerebral vasodilation due to hypercarbia.

Neurological comorbidities resulting in chronically elevated ICP-pseudotumor cerebri and idiopathic intracranial hypertension-may develop in morbidly obese individuals without discernable clinical manifestations.

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) .

A study on ultrasonographic measurement of ONSD laparoscopic radical prostatectomy with steep Trendelenburg positioning revealed that ONSD increased approximately 12.5% and the increase of ICP corresponding to change of ONSD could be predicted. However, no study measured the changes of ONSD according to the positional change with reversed Trendelenburg position during laparoscopic sleeve gastrectomy. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: optic nerve sheath diameter by using ocular sonography

Diagnostic Test: ultrasonographic measurement of the optic nerve sheath diameter
Assessing the optic nerve sheath diameter as an indicator of intracranial pressure during different positions and on specific time intervals in patients undergoing laparoscopic sleeve gastrectomy

Outcome Measures

Primary Outcome Measures

  1. optic nerve sheath diameter [3 months]

    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

Secondary Outcome Measures

  1. Mean blood pressure (MBP) [3 months]

    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

  2. Heart rate (HR) [3 months]

    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. Airway peak pressure (Ppeak) [3 months]

    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

  4. ETCO2 [3 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MOHAMMED FAWZI ALI ABOSAMAK, Associate professor of anesthesia, intensive care and pain management, Tanta University
ClinicalTrials.gov Identifier:
NCT05485363
Other Study ID Numbers:
  • 1234
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 3, 2022