Non-invasive Assessment of Intracranial Pressure Using Ocular Sonography in Patients Undergoing Laparoscopic Sleeve Gastrectomy
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
July 29, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedAugust 3, 2022
August 1, 2022
4 months
July 29, 2022
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Mean blood pressure (MBP)
3 months
Heart rate (HR)
3 months
Airway peak pressure (Ppeak)
3 months
ETCO2
3 months
Study Arms (1)
optic nerve sheath diameter by using ocular sonography
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- patients older than 18 years old undergoing laparoscopic sleeve gastrectomy under general anesthesia.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of anesthesia, intensive care and pain management
Study Record Dates
First Submitted
July 29, 2022
First Posted
August 3, 2022
Study Start
September 1, 2022
Primary Completion
January 1, 2023
Study Completion
April 1, 2023
Last Updated
August 3, 2022
Record last verified: 2022-08