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

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04211064
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hypertension	Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Deep neuromuscular block; Procedure: Moderate neuromuscular block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel 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.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.
• Masking: Double (Participant, 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.
• Primary Purpose: Diagnostic
• Official Title: Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial
• Anticipated Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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)

3. Patient satisfaction score [24 hours]

   Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Principal Investigator: Serdar Yeşiltaş, Instructor, BEZMİALEM VAKIF UNIVERSITY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Serdar Yeşiltaş, Principle Investigator, Medical Doctor, Anesthesiology and Reanimation, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT04211064
• Other Study ID Numbers: 54022451-050.05.04-
• First Posted: Dec 26, 2019
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Serdar Yeşiltaş, Principle Investigator, Medical Doctor, Anesthesiology and Reanimation, Bezmialem Vakif University: optic nerve sheath diameter; deep neuromuscular block; moderate neuromuscular block; intracranial hypertension
• Additional relevant MeSH terms: Intracranial Hypertension; Hypertension

Study Results

No Results Posted as of Sep 13, 2021