Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

NCT07162922 | Completed

• 1 other identifier: KSH-ANREA-EC-02
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose The goal of this clinical trial is to learn how different intra-abdominal pressures during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which is a non-invasive marker of intracranial pressure. The study will also evaluate whether these changes are related to symptoms such as headache, confusion, and nausea after surgery. Study Design This is a prospective, randomized, double-blind clinical trial. Patients undergoing elective laparoscopic cholecystectomy will be assigned to one of two groups: Group 1: pneumoperitoneum at 8 mmHg Group 2: pneumoperitoneum at 14 mmHg ONSD will be measured at several time points before, during, and after surgery using transorbital ultrasonography.

Conditions

Perioperative Complication; Pneumoperitoneum; Increased Intracranial Pressure Disorders

Keywords

optic nerve sheath,; ultrasonography,; cholesistectomy,; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

• Effects of Pneumoperitoneum Pressure on ONSD Over Time

  To compare the effect of two different pneumoperitoneum pressures (8 mmHg vs. 14 mmHg) on optic nerve sheath diameter (ONSD) during laparoscopic cholecystectomy. ONSD will be assessed by measuring changes with transorbital ultrasonography at multiple perioperative time points

  T0: Before intubation T1: 30 minutes after the initiation of pneumoperitoneum T2: 5 minutes after extubation T3: 1 hour after extubation T4: 2 hours after extubation

Secondary Outcomes (3)

• Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale

  One hour after surgery

• Number of participants with postoperative vomiting within one hour after surgery

  One hour after surgery

• Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10)

  One hour after surgery

Study Arms (2)

8 mmHg pressure group

ACTIVE COMPARATOR

Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 8 mmHg.

Other: 8 mmHg pressure group

14 mmHg pressure group

ACTIVE COMPARATOR

Patients in this group will undergo laparoscopic cholecystectomy with pneumoperitoneum maintained at 14 mmHg.

Other: 14 mmHg pressure group

Interventions

8 mmHg pressure group OTHER

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 8 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

8 mmHg pressure group

14 mmHg pressure group OTHER

Laparoscopic cholecystectomy will be performed with intra-abdominal pressure maintained at 14 mmHg during insufflation. Standard anesthesia and surgical protocols will be followed.

14 mmHg pressure group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• ASA physical status I-II
• BMI \< 30 kg/m²
• Scheduled for elective laparoscopic cholecystectomy

You may not qualify if:

• Known neurological diseases
• Ocular pathology
• History of elevated intracranial pressure (ICP)
• Pregnancy
• Need for emergency surgery

Sponsors & Collaborators

• Engin Çetin: lead

Study Sites (1)

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

Location

Related Publications (1)

• 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: 28284189 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 9, 2025
• Study Start: September 17, 2025
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)