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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04211064
Acronym
MBLONDE
Enrollment
60
Registered
2019-12-26
Start date
2021-09-30
Completion date
2022-02-28
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension

Keywords

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

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.

Interventions

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

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

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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameterDuring surgerySonographic 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

MeasureTime frameDescription
Headache24 hoursThe 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 score24 hoursNausea-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 score24 hoursPatient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)

Contacts

Primary ContactSerdar Yeşiltaş, Instructor
syesiltas@bezmialem.edu.tr+905423632630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026