Increased Intracranial Pressure Disorders, Perioperative Complication, Pneumoperitoneum
Conditions
Keywords
optic nerve sheath,, ultrasonography,, cholesistectomy,, pneumoperitoneum
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.
Interventions
OTHER8 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.
OTHER14 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.
Sponsors
Engin Çetin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Pneumoperitoneum Pressure on ONSD Over Time | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative nausea assessed by a standardized 4-point nausea scale | One hour after surgery | Postoperative nausea will be assessed one hour after surgery using a standardized 4-point scale (0 = no nausea, 1 = mild, 2 = moderate, 3 = severe). The number and proportion of participants with any nausea (score ≥1) will be recorded. Higher scores indicate worse symptoms. |
| Number of participants with postoperative vomiting within one hour after surgery | One hour after surgery | Occurrence of vomiting will be recorded during the first postoperative hour. The number and percentage of participants experiencing at least one vomiting episode will be documented (yes/no outcome) |
| Severity of postoperative headache assessed by Numerical Rating Scale (NRS, 0-10) | One hour after surgery | Postoperative headache will be evaluated one hour after surgery using a Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst possible pain. Mean NRS scores and the proportion of participants with moderate-to-severe headache (NRS ≥4) will be reported. Higher scores indicate more severe pain. |
Countries
Turkey (Türkiye)
Outcome results
None listed