Clinical trial NCT04211064: Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter
Official title: Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Hypertension
Keywords: optic nerve sheath diameter
deep neuromuscular block
moderate neuromuscular block
intracranial hypertension
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: During surgery
Secondary outcomes:
measure: Headache
timeFrame: 24 hours
measure: Postoperative nausea and vomiting score
timeFrame: 24 hours
measure: Patient satisfaction score
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: BEZMİALEM VAKIF UNIVERSITY
name: Serdar Yeşiltaş, Instructor
role: PRINCIPAL_INVESTIGATOR
References: