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

NCT ID: NCT05185908

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Optic Nerve Sheath Diameter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

The patients undergoing laparoscopic transperitoneal nephrectomy.

Measurement of the optic nerve sheath diameter by ultrasound-guidance.

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Those who have neurological and cerebrovascular disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 25369152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25861241 (View on PubMed)

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 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.

Reference Type BACKGROUND
PMID: 28284189 (View on PubMed)

Atasever AG, Salviz EA, Senturk Ciftci H, Bingul ES, Sivrikoz N, Erdem S, Savran Karadeniz M. The Effects of Lateral 45 degrees Head-Down Position and Carbon Dioxide Pneumoperitoneum on the Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Transperitoneal Nephrectomies: A Prospective Observational Study. J Laparoendosc Adv Surg Tech A. 2023 Feb;33(2):171-176. doi: 10.1089/lap.2022.0344. Epub 2022 Aug 25.

Reference Type DERIVED
PMID: 36036829 (View on PubMed)

Other Identifiers

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OpticNerveSheathIU

Identifier Type: -

Identifier Source: org_study_id

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