Optic Nerve SheathNCT02003768
The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia
A study testing Propofol and Desflurane in people with Optic Nerve Sheath, run by Yonsei University.
Trial summary
The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Optic Nerve Sheath
- What is being tested?
- Propofol and Desflurane
- 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
- Oct 2013to Oct 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia
Who cannot join
- Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
About this study
The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).
- Conditions
- Optic Nerve Sheath
- Being tested
- Propofol, Desflurane
- Keywords
- pneumoperitoneum, optic nerve sheath diameter, laparoscopy, Patients, general anesthesia, diameter
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy.
DesfluraneDrug
80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy.
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Experimental | 2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®) Receives: Drug: Propofol |
| Des | Active comparator | Desflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc) Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ultrasonographic measurement of optic nerve sheath diameter
optic nerve sheath diameter measured by ultrasonography
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve SheathStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003768
- Sponsor's protocol ID
- 4-2013-0626
- Status last verified
- Jul 2014
- First submitted
- 2 Dec 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
PubMed 22258019
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT02003768
- Acronym / sponsor ID
- 4-2013-0626
- Conditions
- Optic Nerve Sheath
- Keywords
- pneumoperitoneum, optic nerve sheath diameter, laparoscopy, Patients, general anesthesia, diameter
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 6 Dec 2013 (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.
The pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA | Experimental | Drug: Propofol2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®) |
| Des | Active comparator | Drug: DesfluraneDesflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy undergoing general anesthesia
Key exclusion criteria (1 listed)
- Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
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 |
|---|---|---|
| Propofol80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy. | Drug | TIVA |
| Desflurane80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy. | Drug | Des |
Primary outcome
the ultrasonographic measurement of optic nerve sheath diameter
Time frame: baseline
optic nerve sheath diameter measured by ultrasonography
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 15 Jul 2014.
- Background: PubMed 22258019Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Desflurane in people with Optic Nerve Sheath, run by Yonsei 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 1 inclusion and 1 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 15 Jul 2014. 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?
the ultrasonographic measurement of optic nerve sheath diameter (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003768, which also lists 1 linked publication.
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 15 Jul 2014.