NCT06464419

Brief Summary

In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 10, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 13, 2024

Last Update Submit

August 2, 2024

Conditions

Keywords

ultrasonography, lithotomy position

Outcome Measures

Primary Outcomes (1)

  • Effect of lithotomy position on optic nerve sheath diameter

    In patients in the lithotomy position, the linear probe of the ultrasound will be placed on the patient's upper eyelid in a transverse and longitudinal manner without applying compression, and the optic nerve's entry into the orbit will be visualized and measured. The increase in the optic nerve sheath diameter will be recorded by measuring at 7 different times in total.Before general anesthesia (t1), 3 minutes (min.) (t2) and 5 min. (t3) after general anesthesia, 3 min. (t4) and 5 min. (t5) after lithotomy position was given, before lithotomy position was corrected (t6) and when 10 minutes after patients go to the recovery room (t7).

    intraoperative and postoperative 10 minutes

Study Arms (1)

Patients who will undergo RIRS surgery

Patients who will undergo RIRS surgery in the lithotomy position

Device: ultrasound

Interventions

Measurement of optic nerve sheath diameter by ultrasound

Patients who will undergo RIRS surgery

Eligibility Criteria

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

A total of 52 patients, ASA I-II, aged between 18-65, who are scheduled for elective RIRS surgery under general anesthesia will be included.

You may qualify if:

  • Patients who give informed consent
  • Patients who will undergo retrograde intrarenal surgery
  • Patients who are fully oriented and cooperative
  • ASA I-II patients
  • Patients between the ages of 18-65

You may not qualify if:

  • Disoriented and uncooperative patients
  • Patients with BMI\>30
  • Patients who have had previous intracranial surgery
  • Patients who have had eye surgery before
  • Patients allergic to the pharmacological agents used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EtlikCityHospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.

  • Besir A, Tugcugil E. Effects of tourniquet usage in lower extremity surgery on optic nerve sheath diameter. Turk J Med Sci. 2018 Oct 31;48(5):980-984. doi: 10.3906/sag-1803-132.

  • 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.

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Cansu Ekici

    EtlikCityHospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 18, 2024

Study Start

June 10, 2024

Primary Completion

August 10, 2024

Study Completion

September 1, 2024

Last Updated

August 5, 2024

Record last verified: 2024-06

Locations