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

Not Applicable

• Conditions: Intracranial Hypertension
• Interventions: Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Deep neuromuscular block; Procedure: Moderate neuromuscular block

• Registration Number: NCT04211064
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Status Verified: 2021-09
• Study Start: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13
• Primary Completion: 2022-01
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep neuromuscular block	Ultrasonographic measurement of optic nerve sheath diameter	Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)
Moderate neuromuscular block	Ultrasonographic measurement of optic nerve sheath diameter	Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)
Deep neuromuscular block	Deep neuromuscular block	Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)
Moderate neuromuscular block	Moderate neuromuscular block	Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter	During surgery	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

Secondary Outcome Measures

Name	Time	Method
Headache	24 hours	The severity of the headache in the first 24 hours postoperatively(0=never, 1= rarely, 2= sometimes, 3= very often, 4= always)
Postoperative nausea and vomiting score	24 hours	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)
Patient satisfaction score	24 hours	Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)