Intracranial HypertensionMBLONDENCT04211064
Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter
A study testing Ultrasonographic measurement of optic nerve sheath diameter, Deep neuromuscular block and Moderate neuromuscular block in people with Intracranial Hypertension, run by Bezmialem Vakif University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- Ultrasonographic measurement of optic nerve sheath diameter, Deep neuromuscular block and Moderate neuromuscular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-65 years
- ASA I-II
- Patients undergoing elective laparoscopic cholecystectomy
Who cannot join
- Intracranial hypertension
- Glaucoma
- Chronic obstructive pulmonary disease
- Pseudotumor cerebri
- Cerebral venous sinus thrombosis
- İntraoperative hemodynamic instability
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial
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.
- Conditions
- Intracranial Hypertension
- Being tested
- Ultrasonographic measurement of optic nerve sheath diameter, Deep neuromuscular block, Moderate neuromuscular block
- Keywords
- optic nerve sheath diameter, deep neuromuscular block, moderate neuromuscular block, intracranial hypertension
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic measurement of optic nerve sheath diameterDiagnostic test
Optic nerve sheath diameter will be measured at both neuromuscular blocks level.
Deep neuromuscular blockProcedure or surgery
Deep neuromuscular block will be obtained via appropriate dose of rocuronium.
Moderate neuromuscular blockProcedure or surgery
Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular block | Other | Patients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5) Receives: Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Deep neuromuscular block |
| Moderate neuromuscular block | Active comparator | Patients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3) Receives: Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter; Procedure: Moderate neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During surgery
Secondary outcomes (3)
Headache
The severity of the headache in the first 24 hours postoperatively(0=never, 1= rarely, 2= sometimes, 3= very often, 4= always)
Measured: 24 hours
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)
Measured: 24 hours
Patient satisfaction score
Patient satisfaction measured using a NRS 1 to 10 (1 = unsatisfied; 10 =very satisfied)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study startSep 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Yeşiltaş, Bezmialem Vakif University
- Investigators
- Serdar Yeşiltaş, Instructor, Principal investigator, BEZMİALEM VAKIF UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211064
- Sponsor's protocol ID
- 54022451-050.05.04-
- Acronym
- MBLONDE
- Status last verified
- Sep 2021
- First submitted
- 4 Dec 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Deep And Moderate Neuromuscular Blockade On Optic Nerve Sheath Diameter İn Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04211064
- Acronym / sponsor ID
- MBLONDE / 54022451-050.05.04-
- Conditions
- Intracranial Hypertension
- Keywords
- optic nerve sheath diameter, deep neuromuscular block, moderate neuromuscular block, intracranial hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular block | Other | Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter, Procedure: Deep neuromuscular blockPatients undergoing deep neuromuscular blockade with rocuronium (TOF -- PTC 1-5) |
| Moderate neuromuscular block | Active comparator | Diagnostic Test: Ultrasonographic measurement of optic nerve sheath diameter, Procedure: Moderate neuromuscular blockPatients undergoing moderate neuromuscular blockade with rocuronium (TOF 1-3) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-65 years
- ASA I-II
- Patients undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (17 listed)
- Intracranial hypertension
- Glaucoma
- Chronic obstructive pulmonary disease
- Pseudotumor cerebri
- Cerebral venous sinus thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic measurement of optic nerve sheath diameterOptic nerve sheath diameter will be measured at both neuromuscular blocks level. | Diagnostic test | Deep neuromuscular block, Moderate neuromuscular block |
| Deep neuromuscular blockDeep neuromuscular block will be obtained via appropriate dose of rocuronium. | Procedure or surgery | Deep neuromuscular block |
| Moderate neuromuscular blockModerate neuromuscular block will be obtained via appropriate dose of rocuronium. | Procedure or surgery | Moderate neuromuscular block |
Primary outcome
Optic nerve sheath diameter
Time frame: 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
3 secondary outcomes
Headache
Time frame: 24 hours
Postoperative nausea and vomiting score
Time frame: 24 hours
Patient satisfaction score
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Yeşiltaş, Instructor principal investigator
BEZMİALEM VAKIF UNIVERSITY
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic measurement of optic nerve sheath diameter, Deep neuromuscular block and Moderate neuromuscular block in people with Intracranial Hypertension, run by Bezmialem Vakif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Yeşiltaş, Instructor (+905423632630, syesiltas@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.