The Effect of Alveolar Recruitment Manoeuvre on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomies

NCT06168578 | Active Not Recruiting

• 1 other identifier: ARM-ONSD-22-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic total hysterectomy is the most common gynaecological surgical procedure after caesarean section. In laparoscopic total hysterectomy, intraabdominal pressure increases, venous return decreases, hypercarbia and acidosis may occur due to pneumoperitoneum due to CO2 insufflation and upright trendelenburg position (TP). Cerebral blood flow, intracranial pressure (ICP) and intraocular pressure (IOP) increase. One study showed that TP and an intraabdominal pressure of mmHg significantly increased ICP. CO2 insufflation into the abdominal cavity causes upward displacement of the diaphragm, resulting in an increased risk of regurgitation, decreased lung volumes and compliance, atelectasis, increased airway resistance and ventilation-perfusion mismatch. At the same time, combined with the effects of general anaesthesia, a decrease in partial arterial oxygen pressure (PaO2) is expected in patients. The alveolar recirculation manoeuvre (ARM), is based on the technique of opening atelectatic lung fields by keeping the airway pressure high for a while. This manoeuvre can be performed with methods such as PEEP, CPAP, and pressure-controlled mechanical ventilation. High PEEP application may cause an increase in ICP and a decrease in cerebral perfusion pressure by increasing intrathoracic pressure and decreasing cerebral venous return. Therefore, intracranial pressure monitoring should be performed especially in patients with PEEP above 8-10 cmH2O. Intraventricular and intraparenchymal measurements, which are the gold standard methods for ICP monitoring, are invasive procedures with various risks. Noninvasive methods such as cranial CT, brain MRI, transcranial Doppler, and measurement of optic nerve sheath diameter (ONSD) can also be used for ICP measurement. Ultrasonography of the optic nerve sheath diameter is an increasingly common method because it is noninvasive and can be performed at the bedside. The optic nerve sheath is the continuation of the transverse subarachnoid space and the cerebral duramater. It is connected to the intracranial subarachnoid space with cerebrospinal fluid. Therefore, an increase in ICP increases the optic nerve sheath diameter (ONSD). Maissan et al. They think that ONSD reflects the changes in ICP simultaneously. The aim of this study was to evaluate the effect of ARM on intracranial pressure in patients undergoing total laparoscopic hysterectomy under general anaesthesia using optic nerve sheath diameter.

Conditions

Recruitment; Optic Nerve; Hysterectomy

Keywords

alveolar recruitment; optical diameter; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• ICP

  The aim of this study was to evaluate the effect of alveolar recruitment manoeuvre (ARM) on intracranial pressure in patients undergoing total laparoscopic hysterectomy under general anaesthesia using the diameter of the optic nerve sheath.

  inoperation

Study Arms (2)

Group I (ARM-): After intubation, 5 cmH2O PEEP will be applied until the end of the operation

* First ONSD measurement will be performed 5 minutes after intubation with the patient in supine position (T0) * A second ONSD measurement will be performed 10 minutes after intubation with the patient in supine position. (T1) * ONSD will be measured for the third time 5 minutes after pneumoperitoneum is established with 12-13 mmHg. (T2) * At 10 minutes of Trendelenburg position (45⁰), ONSD will be measured for the fourth time (T3). * In Trendelenburg position (45⁰), ONSD will be measured for the fifth time after removal of the uterus. (T4) * After the supine position is assumed before extubation and pneumoperitoneum is terminated, ONSD will be measured for the sixth time before the neuromuscular blocker is reversed. (T5)

Device: ultrasound

Group II (ARM+): After intubation, 5 cmH2O PEEP will be applied until the end of the operation

* ONSD will be measured 5 minutes after intubation with the patient in supine position (T0) * ARM will be applied 10 minutes after intubation, and ONSD will be measured for the second time when the peak pressure is reached. (T1) * ONSD will be measured for the third time 5 minutes after pneumoperitoneum is established with 12-13 mmHg. (T2) * At 10 minutes of Trendelenburg position (45⁰), ONSD will be measured for the fourth time (T3). * Trendelenburg position (45⁰), ARM will be applied after the uterus is removed, and ONSD will be measured for the fifth time when the peak pressure is reached. (T4) * After the supine position is assumed before extubation and pneumoperitoneum is terminated, ONSD will be measured for the sixth time before the neuromuscular blocker is reversed. (T5)

Device: ultrasound

Interventions

ultrasound DEVICE

Optic nerve diameter will be measured by ultrasound at certain stages of the operation in Group I (ARM-) and Group II (ARM+)

Group I (ARM-): After intubation, 5 cmH2O PEEP will be applied until the end of the operation; Group II (ARM+): After intubation, 5 cmH2O PEEP will be applied until the end of the operation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 18-65 years * Female volunteers

You may qualify if:

• Elective total laparoscopic hysterectomy under general anaesthesia
• years
• ASA I-II
• Female volunteers with a body mass index (BMI) ≤35 kg/m2 with written informed consent will be included in the study

You may not qualify if:

• Previous eye surgery, ophthalmic disease
• Previous neurosurgery
• Transient ischaemic attack, other neurological diseases affecting the eye or that may affect ICP
• Previous lung surgery, pneumothorax
• Pulmonary diseases (emphysema, pneumonia, malignancy)
• Patients in whom the surgical plan has changed (open/complicated surgery) will not be included in the study

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University Faculty of Medicine

Balıkesir, Turkey (Türkiye)

Location

Related Publications (3)

• Huynh T, Messer M, Sing RF, Miles W, Jacobs DG, Thomason MH. Positive end-expiratory pressure alters intracranial and cerebral perfusion pressure in severe traumatic brain injury. J Trauma. 2002 Sep;53(3):488-92; discussion 492-3. doi: 10.1097/00005373-200209000-00016.

  PMID: 12352486 BACKGROUND

• Killer HE, Laeng HR, Flammer J, Groscurth P. Architecture of arachnoid trabeculae, pillars, and septa in the subarachnoid space of the human optic nerve: anatomy and clinical considerations. Br J Ophthalmol. 2003 Jun;87(6):777-81. doi: 10.1136/bjo.87.6.777.

  PMID: 12770980 BACKGROUND

• Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.

  PMID: 25955869 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nazan Kocaoglu

  Balikesir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: January 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: April 15, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study is completed
• Access Criteria: only university researchers

Locations

TU (1)