Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter

Study Overview
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Brief Summary
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Increased intracranial pressure (IICP) is a common problem in traumatic brain injuries and many medical diseases. Early recognition of IICP can save lives. Several invasive and non-invasive methods have been described for IICP diagnosis. In recent years, ultrasonographic measurement of optic nerve sheath diameter (ONSD) has become a popular method due to its high sensitivity and specificity for IICP estimation. Studies have shown that ONSD's ultrasonographic measurement correlates with the IICP and can detect intracranial hypertension. The ONSD measurement has advantages such as being easily applied by the clinician at the bedside, being non-invasive, providing immediate results, reproducibility and low cost. It is known that artificial carbon dioxide pneumoperitoneum created in laparoscopic surgeries increases intracranial pressure.However, it is not easy to estimate the degree of changes in ICP during laparoscopic surgery under general anesthesia. In the literature, there are many studies on the sonographic measurement of optic nerve sheath diameter to evaluate the effects of trendelenburg position on intracranial pressure with the use of different anesthetic drugs in laparoscopic surgeries. In addition, there are studies reporting that deep neuromuscular blockade in laparoscopic surgeries increases surgical vision and decreases analgesic requirement in postoperative period. The relationship between neuromuscular block level and intracranial pressure is not clear. From this point of view, the investigators would like to evaluate the effect of moderate and deep neuromuscular block level on intracranial pressure by sonographic measurement of optic nerve sheath diameter in laparoscopic cholecystectomy operations performed with standard pressure artificial carbon dioxide pneumoperitoneum.

Official Title
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Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Conditions
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Intracranial Hypertension

Intervention / Treatment
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* Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter
* Procedure: Deep neuromuscular block
* Procedure: Moderate neuromuscular block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18-65 years ASA I-II Patients undergoing elective laparoscopic cholecystectomy Exclusion Criteria: Intracranial hypertension Glaucoma Chronic obstructive pulmonary disease Pseudotumor cerebri Cerebral venous sinus thrombosis İntraoperative hemodynamic instability Mean arterial blood pressure<65 mmHg Body mass index> 35 Asthma Kidney or liver problems Lupus Crohn's disease or ulcerative colitis Previously had any gastrointestinal bleeding Hypertension Peripheral arterial disease Angina, heart attacks, or mild or moderate heart failure Stroke

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly divided into 2 groups. In the first group (Group 1), patients undergoing intraabdominal insufflation pressure 12 mmHg and deep neuromuscular block (TOF -- PTC 1-5), in the second group (Group 2) patients undergoing intraabdominal insufflation pressure 12 mmHg and moderate neuromuscular block (TOF 1-3) It would be classified.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Deep neuromuscular block<br>Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5) | Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter<br>* Optic nerve sheath diameter will be measured at both neuromuscular blocks level.<br>Procedure: Deep neuromuscular block<br>* Deep neuromuscular block will be obtained via appropriate dose of rocuronium.<br>|
| Active Comparator: Moderate neuromuscular block<br>Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3) | Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter<br>* Optic nerve sheath diameter will be measured at both neuromuscular blocks level.<br>Procedure: Moderate neuromuscular block<br>* Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic nerve sheath diameter | Sonographic optic nerve sheath measurements will be made 5 times, preoperatively, 5 minutes after endotracheal intubation, 5 minutes after pneumoperitoneum, 5 minutes after pneumoperitoneum is terminated and after extubation | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache | The severity of the headache in the first 24 hours postoperatively(0=never, 1= rarely, 2= sometimes, 3= very often, 4= always) | 24 hours | 
| Postoperative nausea and vomiting score | Nausea-vomiting were assessed with postoperative nausea and vomiting scale (PONV) (0=no PONV, 1= mild nausea, 2= severe nausea or vomiting once, 3= vomiting more than once) | 24 hours | 
| Patient satisfaction score | Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optic nerve sheath diameter, deep neuromuscular block, moderate neuromuscular block, intracranial hypertension