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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
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 4, 2019
    Last Updated
    September 6, 2021
    Sponsor
    Bezmialem Vakif University
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    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

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

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