Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg

Status Completed

Clinical Trial 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.

Clinical Trial Description

The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum. The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may occur. 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. The optic nerve is an extension of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the nerve sheath. 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. In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position. Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our secondary aim is to evaluate the effect of this change on intracranial pressure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04428229
Study type	Observational
Source	Medipol University
Contact
Status	Completed
Phase
Start date	July 15, 2020
Completion date	April 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05509244` - Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery	N/A
Recruiting	`NCT04963751` - ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling	N/A
Recruiting	`NCT05125692` - Vaginal Repair of Post Cesarean Istmocele	N/A
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Not yet recruiting	`NCT05974995` - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer	N/A
Completed	`NCT06011928` - MOPEXE and RE in Treating Dysmenorrhea	N/A
Completed	`NCT04839263` - Fast-track in Minimally Invasive Gynaecology	N/A
Completed	`NCT04498208` - Immune Modulation by Enhanced vs Standard Prehabilitation Program Before Major Surgery	N/A
Completed	`NCT04642118` - Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery	N/A
Completed	`NCT03820115` - Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions	N/A
Recruiting	`NCT03327506` - Preoperative Hypnosis Versus Premedication in Gynecological Surgery	Phase 4
Recruiting	`NCT02957500` - To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)	N/A
Completed	`NCT02476799` - Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery	N/A
Recruiting	`NCT06425484` - The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.	N/A
Completed	`NCT02450084` - Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery	N/A
Completed	`NCT03916445` - Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases
Completed	`NCT05325619` - Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management
Not yet recruiting	`NCT05781581` - A Retrospective Cohort Study for Main Postoperative Complications After SARS-CoV-2 Infection
Recruiting	`NCT03427840` - Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
Completed	`NCT03884244` - Postoperative Chewing Gum and Gynecological Laparoscopic Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms