Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter (MBLONDE)
Primary Purpose
Intracranial Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonographic measurement of optic nerve sheath diameter
Deep neuromuscular block
Moderate neuromuscular block
Sponsored by
About this trial
This is an interventional diagnostic trial for Intracranial Hypertension focused on measuring optic nerve sheath diameter, deep neuromuscular block, moderate neuromuscular block, intracranial hypertension
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Deep neuromuscular block
Moderate neuromuscular block
Arm Description
Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)
Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Headache
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
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
Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)
Full Information
NCT ID
NCT04211064
First Posted
December 4, 2019
Last Updated
September 6, 2021
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04211064
Brief Title
Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
optic nerve sheath diameter, deep neuromuscular block, moderate neuromuscular block, intracranial hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep neuromuscular block
Arm Type
Other
Arm Description
Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5)
Arm Title
Moderate neuromuscular block
Arm Type
Active Comparator
Arm Description
Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3)
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasonographic measurement of optic nerve sheath diameter
Intervention Description
Optic nerve sheath diameter will be measured at both neuromuscular blocks level.
Intervention Type
Procedure
Intervention Name(s)
Deep neuromuscular block
Intervention Description
Deep neuromuscular block will be obtained via appropriate dose of rocuronium.
Intervention Type
Procedure
Intervention Name(s)
Moderate neuromuscular block
Intervention Description
Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.
Primary Outcome Measure Information:
Title
Optic nerve sheath diameter
Description
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
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Headache
Description
The severity of the headache in the first 24 hours postoperatively(0=never, 1= rarely, 2= sometimes, 3= very often, 4= always)
Time Frame
24 hours
Title
Postoperative nausea and vomiting score
Description
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)
Time Frame
24 hours
Title
Patient satisfaction score
Description
Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Yeşiltaş, Instructor
Phone
+905423632630
Email
syesiltas@bezmialem.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Yeşiltaş, Instructor
Organizational Affiliation
BEZMİALEM VAKIF UNIVERSITY
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter
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