NCT06168578

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

StatusCompleted

PhaseNot specified

SponsorBalikesir University

Primary completionAug 15, 2026

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

Notable Oct 5, 2026 Primary completion date changed from estimate of Dec 15, 2025 to Aug 15, 2026 Show 5 more changesShow less
- Trial completed
- Study completion date changed from estimate of Apr 15, 2026 to Sep 15, 2026
- Eligibility criteria expanded, about 10 words
- Study description expanded, about 22 words
- Publications: details revised at 3 of 3 entries
Notable Sep 22, 2025 Primary completion date: Jun 15, 2025 to Dec 15, 2025
- Study completion date: Dec 15, 2025 to Apr 15, 2026
v5
Notable Nov 15, 2024 Primary completion date: Sep 15, 2024 to Jun 15, 2025
- Study completion date: Dec 15, 2024 to Dec 15, 2025
v4
Minor Aug 13, 2024 Primary completion date: May 15, 2024 to Sep 15, 2024
- Study completion date: Aug 15, 2024 to Dec 15, 2024
v3
Minor Mar 12, 2024 Trial status: Not Yet Recruiting to Active, Not Recruiting
- Site contact updated
v2
Dec 5, 2023 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

ICP

Timeframe: inoperation

Arms and interventions

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)

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)

Devices: ultrasound

Sites

1 site in 1 country

Balikesir University Faculty of MedicineBalıkesir, Turkey (Türkiye)

About this trial

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.

Trial details

Enrollment: 60 participants (actual)
Started: Jan 15, 2024
Study completion: Sep 15, 2026
Eligibility: 18 to 65, female only, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Recruitment, Optic Nerve, Hysterectomy
First posted: Dec 13, 2023
Registry updated: Oct 8, 2026
Last verified: Sep 2025

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