Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low pressure group, Normal pressure group.
- Who it may be relevant to
- Registry conditions: Intracranial Pressure Increase, Abdominal Pain, Head Pain. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Gyneco-oncologic Surgeries
Overview
The aim of this study is to investigate the effects of low and normal intraperitoneal pressures on intraoperative optic nerve sheath diameter in laparoscopic gyneco-oncologic surgeries.
Detailed description
Gynecological surgeries are minimally invasive procedures. The establishment of pneumoperitoneum, special patient positioning, and surgical stimulation can induce a stress response in patients. Carbon dioxide (CO₂) pneumoperitoneum and the Trendelenburg position lead to increases in intra-abdominal, intrathoracic, and airway pressures, which in turn may directly or indirectly cause elevations in intracranial and intraocular pressures.
During the perioperative period, the optic nerve sheath diameter (ONSD), measured ultrasonographically, is used as a reliable method to estimate intracranial pressure (ICP). Monitoring ICP under anesthesia may help prevent neurological complications such as neurological deterioration and optic neuropathy. Furthermore, studies have demonstrated ICP changes in robotic and laparoscopic gynecologic surgeries through ultrasonographic measurement of ONSD.
Traditionally, laparoscopic abdominal surgeries are performed using intraperitoneal pressures ranging between 10 and 18 mmHg. Lower intra-abdominal pressures have been associated with reduced postoperative pain, improved pulmonary parameters, and a decreased risk of gas embolism. However, the data on these outcomes remain limited.
In this study, we aimed to investigate the effect of pressures above and below 12 mmHg on the optic nerve sheath diameter-and consequently on intracranial pressure-in patients undergoing laparoscopic gynecologic surgery.
Interventions
- Other Low pressure group
In laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure. - Other Normal pressure group
In laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure.
Primary outcome measures
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: 30 minutes after introducing pneumoperitoneum and position change]
Secondary outcome measures (5)
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation]
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: 5 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: 60 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: 90 minutes after introducing pneumoperitoneum and position change]
- Measurement of optic nerve sheath diameter (ONSD) [Time frame: The ONSD measurement will be performed 5 minutes after the pneumoperitoneum is released and the Trendelenburg position is corrected.]
Eligibility criteria
Inclusion criteria
- Laparoscopic gyneco-oncological surgeries
- Female patients aged 18-65 years
- ASA physical status classification I-II-III patients
Exclusion criteria
- Patients with diabetic retinopathy
- Patients with glaucoma
- Patients with cerebrovascular disease
- Pregnant women
- Patients with known allergy to anaesthetic agents
- Morbidly obese patients with BMI > 40
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Zeynep Koç — Yenimahalle
Publications
- Lee YY, Lee H, Park HS, Kim WJ, Baik HJ, Kim DY. Optic nerve sheath diameter changes during gynecologic surgery in the Trendelenburg position: comparison of propofol-based total intravenous anesthesia and sevoflurane anesthesia. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):393-400. doi: 10.17085/apm.2019.14.4.393. PMID 33329767
- Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7. PMID 33504329
- Kim SH, Kim HJ, Jung KT. Position does not affect the optic nerve sheath diameter during laparoscopy. Korean J Anesthesiol. 2015 Aug;68(4):358-63. doi: 10.4097/kjae.2015.68.4.358. Epub 2015 Jul 28. PMID 26257848
Identifiers
NCT: NCT07155109 · ZeynepKoc005