Intracranial HypertensionNCT02753205
Dexmedetomidine on Optic Nerve Sheath Diameter
A study testing Dexmedetomidine and normal saline in people with Intracranial Hypertension, run by Gachon University Gil Medical Center.
Trial summary
Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of colorectal cancer
- planed for laparoscopic low anterior resection
Who cannot join
- morbid obesity (body mass index > 30 kg.m-2)
- history of cerebrovascular disease
- history of respiratory disease
- uncontrolled cardiovascular disease
About this study
Official title: Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection
Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.
Read the detailed description
Laparoscopic lower abdominal surgery requires the Trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. Dexmedetomidine, a selective alpha2 receptor agonist might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.
- Conditions
- Intracranial Hypertension
- Being tested
- Dexmedetomidine, normal saline
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called dex
infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery
normal salineDrug
Also called NS
infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Infusion of normal saline Receives: Drug: normal saline |
| Dexmedetomidine | Active comparator | infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
mm
Measured: Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min
Secondary outcomes (1)
Respiratory and mean arterial pressure
mmHg
Measured: Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jeong Kwak, Gachon University Gil Medical Center
- Investigators
- Kyung Cheon Lee, Study chair, Gachon Universtiy Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753205
- Sponsor's protocol ID
- GCIRB2016-058
- Status last verified
- Nov 2016
- First submitted
- 14 Apr 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection
- ClinicalTrials.gov ID
- NCT02753205
- Acronym / sponsor ID
- GCIRB2016-058
- Conditions
- Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- 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.
Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.
Detailed description
Laparoscopic lower abdominal surgery requires the Trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. Dexmedetomidine, a selective alpha2 receptor agonist might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: normal salineInfusion of normal saline |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidineinfusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of colorectal cancer
- planed for laparoscopic low anterior resection
Key exclusion criteria (4 listed)
- morbid obesity (body mass index > 30 kg.m-2)
- history of cerebrovascular disease
- history of respiratory disease
- uncontrolled cardiovascular disease
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 |
|---|---|---|
| DexmedetomidineAlso: dexinfusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery | Drug | Dexmedetomidine |
| normal salineAlso: NSinfusion of normal saline | Drug | Control |
Primary outcome
Optic nerve sheath diameter
Time frame: Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min
mm
1 secondary outcome
Respiratory and mean arterial pressure
Time frame: Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Kyung Cheon Lee study chair
Gachon Universtiy Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and normal saline in people with Intracranial Hypertension, run by Gachon University Gil Medical Center.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Nov 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (time frame: Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min). 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 10 Nov 2016.