The Effects of Lateral 45° Downward Position on the Optic Nerve Sheath Diameter

Optic Nerve Sheath Diameter Clinical Trial

Official title:

The Effects of Lateral 45° Downward Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05185908
• Other study ID #: OpticNerveSheathIU
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: December 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Trendelenburg position and carbon dioxide (CO2) pneumoperitoneum are in association with increased intracranial pressure (ICP) reflected by the optic nerve sheath diameter (ONSD). Measurement of ONSD by ultrasound (US) guidance can be used in the diagnosis of ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.

Description:

Transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. This technique requires a steep (35° to 45°) lateral downward (SLD) position and a CO2 pneumoperitoneum. SLD may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. These are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ION) after a da Vinci robotic-assisted procedure. SLD has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ION. However, a few investigations have yet been made into intraoperative changes in intraocular pressure (IOP) and optic nerve sheath diameter (ONSD) - correlating with intracranial pressure (ICP) - and their adverse ocular effects. The operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. The hypothesis of the study is that patients placed in SLD for several hours have a high risk for ocular changes and peri- and postoperative complications. The aim of this study was to investigate the influence of capnoperitoneum and permanent 45° SLD on IOP and ONSD in patients undergoing laparoscopic transperitoneal nephrectomy. The investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. Perioperative and postoperative complications were also recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 1, 2019
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy.

Exclusion Criteria:

• Those who have neurological and cerebrovascular disease.

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter
• Pneumoperitoneum

Intervention

Procedure:
• Measurement of the optic nerve sheath diameter by ultrasound-guidance.
Measurement of the optic nerve sheath diameter (ONSD) by ultrasound guidance can be used in the diagnosis of increased ICP. The investigators interrogated the effects of lateral 45° downward position and CO2 insufflation on ONSD in patients undergoing laparoscopic transperitoneal nephrectomy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

References & Publications (3)

Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45° Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3. — View Citation

Chin JH, Seo H, Lee EH, Lee J, Hong JH, Hwang JH, Kim YK. Sonographic optic nerve sheath diameter as a surrogate measure for intracranial pressure in anesthetized patients in the Trendelenburg position. BMC Anesthesiol. 2015 Mar 31;15:43. doi: 10.1186/s12871-015-0025-9. eCollection 2015. — View Citation

Verdonck P, Kalmar AF, Suy K, Geeraerts T, Vercauteren M, Mottrie A, De Wolf AM, Hendrickx JF. Optic nerve sheath diameter remains constant during robot assisted laparoscopic radical prostatectomy. PLoS One. 2014 Nov 4;9(11):e111916. doi: 10.1371/journal.pone.0111916. eCollection 2014. Erratum in: PLoS One. 2015;10(2):e0118014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	optic nerve sheath diameter	Measurement of optic nerve sheath diameter by ultrasound (US) guidance can be used in the diagnosis of increased intracranial pressure (ICP).	up to 24 hours
Secondary	Respiratory parameters	Peak inspiratory pressure	up to 24 hours
Secondary	Hemodynamic parameters	Mean arterial pressure	up to 24 hours