Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position

NCT04428229 | Completed

• 1 other identifier: Medipol Hospital 14
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

It is difficult to measure the several levels of intracranial pressure during abdominal surgery, and direct monitoring with intracranial devices is often impossible. Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative method for evaluating intracranial pressure. Increased intracranial pressure may cause in expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method to evaluate intracranial pressure.

Conditions

Colon Disease; Gynecologic Disease

Keywords

Trendelenburg position; Optic nerve sheath diameter; Colon surgery; Gynecologic surgery

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter

  Pre and post-trendelenburg diameters of optic nerve sheath

  Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position

Interventions

Optic nerve sheath diameter OTHER

Pre and post-trendelenburg optic nerve sheath diameter will be measured

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Laparoscopic colon and gynecologic surgery patients aged between 18-75 years with ASA I and ASA II status will be included in this randomized prospective study.

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia

You may not qualify if:

• use of beta blocker or diuretic drugs
• severe heart failure
• diabetes with ocular or neurologic complications
• history of cardiac, eye, intracranial, and thoracic surgery
• history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (3)

• Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.

  PMID: 27956677 BACKGROUND

• Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794.

  PMID: 31124975 BACKGROUND

• Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.

  PMID: 31691148 BACKGROUND

MeSH Terms

Conditions

Colonic Diseases; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 15, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)