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

NCT04211064 | Unknown

• 1 other identifier: 54022451-050.05.04-
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracranial Hypertension

Keywords

optic nerve sheath diameter; deep neuromuscular block; moderate neuromuscular block; intracranial hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Headache

  24 hours

• Postoperative nausea and vomiting score

  24 hours

• Patient satisfaction score

  24 hours

Study Arms (2)

Deep neuromuscular block

OTHER

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

Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Deep neuromuscular block

Moderate neuromuscular block

ACTIVE COMPARATOR

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

Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Moderate neuromuscular block

Interventions

Ultrasonographic measurement of optic nerve sheath diameter DIAGNOSTIC_TEST

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

Deep neuromuscular block; Moderate neuromuscular block

Deep neuromuscular block PROCEDURE

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

Deep neuromuscular block

Moderate neuromuscular block PROCEDURE

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

Moderate neuromuscular block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-65 years
• ASA I-II
• Patients undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Serdar Yeşiltaş, Instructor

  BEZMİALEM VAKIF UNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Yeşiltaş, Instructor

CONTACT

+905423632630; syesiltas@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Medical Doctor, Anesthesiology and Reanimation

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 26, 2019
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09