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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Hypertension
• Intervention / Treatment: Diagnostic test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Deep neuromuscular block; Procedure: Moderate neuromuscular block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serdar Yeşiltaş, Instructor; Phone Number: +905423632630; Email: syesiltas@bezmialem.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: intracranial hypertension; optic nerve sheath diameter; deep neuromuscular block; moderate neuromuscular block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension
• Other Study ID Numbers: 54022451-050.05.04-

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No