NCT05185908

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

December 5, 2021

Last Update Submit

December 22, 2021

Conditions

Keywords

Carbondioxide pneumoperitoneumOptic nerveNephrectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Respiratory parameters

    up to 24 hours

  • Hemodynamic parameters

    up to 24 hours

Study Arms (1)

Group 1

The patients undergoing laparoscopic transperitoneal nephrectomy.

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

Interventions

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.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-six patients who have undergone laparoscopic transperitoneal nephrectomy in the period of December 2016 and February 2017 were included in this study.

You may qualify if:

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

You may not qualify if:

  • Those who have neurological and cerebrovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25369152BACKGROUND
  • 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.

    PMID: 25861241BACKGROUND
  • 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.

    PMID: 28284189BACKGROUND
  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 5, 2021

First Posted

January 11, 2022

Study Start

December 1, 2016

Primary Completion

March 2, 2017

Study Completion

January 1, 2019

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share