Different Intraperitoneal Pressures on Optic Nerve Sheath Diameter in Laparoscopic Surgeries

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorDiskapi Yildirim Beyazit Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Laparoscopic gyneco-oncological surgeries

Female patients aged 18-65 years

ASA physical status classification I-II-III patients

Disqualifiers

Patients with diabetic retinopathy

Patients with glaucoma

Patients with cerebrovascular disease

Pregnant women

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low pressure group

    Other intervention

    In laparoscopic gyneco-oncological surgeries, low pressure group will receive below 12 mmHg intraperitoneal pressure.

  • Normal pressure group

    Other intervention

    In laparoscopic gyneco-oncological surgeries, normal pressure group will receive 12 and abowe 12 mmHg intraperitoneal pressure.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Low Pressure GroupExperimental treatment 1 intervention
Group B: Normal Pressure GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement of optic nerve sheath diameter (ONSD)

ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.

Time frame
30 minutes after introducing pneumoperitoneum and position change

Secondary outcomes

1

Measurement of optic nerve sheath diameter (ONSD)

ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.

Time frame
The baseline ONSD measurement will be performed 5 minutes after endotracheal intubation
2

Measurement of optic nerve sheath diameter (ONSD)

ONSD will be measured in the supine position by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.

Time frame
5 minutes after introducing pneumoperitoneum and position change
3

Measurement of optic nerve sheath diameter (ONSD)

ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.

Time frame
60 minutes after introducing pneumoperitoneum and position change
4

Measurement of optic nerve sheath diameter (ONSD)

ONSD will be measured by ulrasonographic measurement.After obtaining optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band, the ONSD will be measured 3 mm behind the optic disc using an electronic caliper. The final ONSD value was calculated by averaging 4 measured values: measured values of transverse and sagittal plane of both eyes.

Time frame
90 minutes after introducing pneumoperitoneum and position change

Other outcomes

1

numerical rating scale (NRS) at rest

Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient

Time frame
popstoperative 1. hour
2

numerical rating scale (NRS) at rest

Recording the patient's pain at rest on the Numerical Rating Scale (NRS) by asking the patient

Time frame
popstoperative 8. hours
3

postoperative nosia and vomiting (PONV)

Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively

Time frame
popstoperative 1. hour
4

postoperative nosia and vomiting (PONV)

Recording the presence or absence of nausea and vomiting in the patient within the first 24 hours postoperatively

Time frame
popstoperative 8. hours

Sponsors and contacts

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