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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-02-28

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.

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Detailed Description

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Conditions

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Intracranial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

The participants were blinded to group allocation, as the measurements were performed after induction of general anesthesia. The investigator measuring the optic nerve sheath diameter was blinded to the group assignment.

Study Groups

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Deep neuromuscular block

Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)

Group Type OTHER

Ultrasonographic measurement of optic nerve sheath diameter

Intervention Type DIAGNOSTIC_TEST

Optic nerve sheath diameter will be measured at both neuromuscular blocks level.

Deep neuromuscular block

Intervention Type PROCEDURE

Deep neuromuscular block will be obtained via appropriate dose of rocuronium.

Moderate neuromuscular block

Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)

Group Type ACTIVE_COMPARATOR

Ultrasonographic measurement of optic nerve sheath diameter

Intervention Type DIAGNOSTIC_TEST

Optic nerve sheath diameter will be measured at both neuromuscular blocks level.

Moderate neuromuscular block

Intervention Type PROCEDURE

Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.

Interventions

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Ultrasonographic measurement of optic nerve sheath diameter

Optic nerve sheath diameter will be measured at both neuromuscular blocks level.

Intervention Type DIAGNOSTIC_TEST

Deep neuromuscular block

Deep neuromuscular block will be obtained via appropriate dose of rocuronium.

Intervention Type PROCEDURE

Moderate neuromuscular block

Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes