Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomy

NCT ID: NCT07162922

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2025-12-21

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.

Detailed Description

Purpose The aim of this clinical trial is to investigate how different intra-abdominal pressures applied during laparoscopic cholecystectomy affect the optic nerve sheath diameter (ONSD), which serves as a reliable, non-invasive marker of intracranial pressure. The study also seeks to determine whether perioperative ONSD changes are associated with postoperative symptoms such as headache, nausea, and disorientation, as well as with recovery parameters and hemodynamic stability.

Study Design

This is a prospective, randomized, double-blind, interventional clinical trial. Eligible patients scheduled for elective laparoscopic cholecystectomy will be randomized into two groups based on pneumoperitoneum pressure:

Group 1 (Low-pressure group): pneumoperitoneum maintained at 8 mmHg Group 2 (High-pressure group): pneumoperitoneum maintained at 14 mmHg

ONSD will be measured via transorbital ultrasonography at standardized perioperative time points:

T0: Before induction of anesthesia

T1: 30 minutes after initiation of pneumoperitoneum

T2: 5 minutes after extubation

T3: 1 hour postoperatively

T4: 2 hours postoperatively

All ultrasonographic assessments will be performed by a trained investigator blinded to the patient's group allocation.

Participation Patients will receive anesthesia and undergo laparoscopic cholecystectomy according to standard surgical protocols.

Each participant will be randomly assigned to one of the two pneumoperitoneum pressure groups (8 mmHg or 14 mmHg).

After surgery, patients will be observed in the recovery unit. Postoperative symptoms including headache, nausea and vomiting will be recorded.

Conditions

Increased Intracranial Pressure Disorders; Perioperative Complication; Pneumoperitoneum

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

8 mmHg pressure group

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

Group Type: ACTIVE_COMPARATOR

8 mmHg pressure group

Intervention Type: OTHER

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

14 mmHg pressure group

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

Group Type: ACTIVE_COMPARATOR

14 mmHg pressure group

Intervention Type: OTHER

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

Interventions

8 mmHg pressure group

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

Intervention Type: OTHER

14 mmHg pressure group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-65 years of age
• ASA physical status I-II
• BMI < 30 kg/m²
• Scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engin Çetin

OTHER_GOV

Sponsor Role: lead

Responsible Party

Engin Çetin

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28284189 (View on PubMed)

Other Identifiers

KSH-ANREA-EC-02

Identifier Type: -

Identifier Source: org_study_id