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

Intracranial Hypertension Clinical Trial

— MBLONDE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04211064
• Other study ID #: 54022451-050.05.04-
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: February 2022

Study information

• Verified date: September 2021
• Source: Bezmialem Vakif University
• Contact: Serdar Yesiltas, Instructor
• Phone: +905423632630
• Email: syesiltas[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• Intraoperative 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

Related Conditions & MeSH terms

• Hypertension
• Intracranial Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient satisfaction score	Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)	24 hours