Laparoscopic Gynecologic SurgeryEarly Phase 1NCT03498235
Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery
A Early Phase 1 study testing Sevoflurane and Propofol in people with Laparoscopic Gynecologic Surgery, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Laparoscopic Gynecologic Surgery
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to Jun 2020
- Phase
- Early Phase 1
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status diagnosed as I or II
Who cannot join
- neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
About this study
Official title: Randomized,Double-Blind Trial A Comparative Analysis of the Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Steep Trendelenburg Position and Pneumoperitoneum for Laparoscopic Gynecologic Surgery
Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.
Read the detailed description
Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises.
Sevoflurane and propofol have different effects on ICP.When sevoflurane concentration >1.1 minimum alveolar concentration（MAC),ICP increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and ICP decreases.
ICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum .
Meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.
- Conditions
- Laparoscopic Gynecologic Surgery
- Being tested
- Sevoflurane, Propofol
- Keywords
- sevoflurane, propofol, intracranial pressure, optic nerve sheath diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
In Team Sevoflurane,patients undergo sevoflurane.
PropofolDrug
In Team Propofol ,anesthesia is maintained with propofol
| Study group | Role | What they receive |
|---|---|---|
| Team Sevoflurane | Experimental | Not described Receives: Drug: Sevoflurane |
| Team Propofol | Experimental | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of ultrasonographic optic nerve sheath diameter
different time including pre-anesthesia, after intubation,every 15 minutes in the first hour after beginning of surgery, every hour when one hour after surgery beginning,surgery ending.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Secondary outcomes (5)
Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.
Mean arterial pressure was collected when measures ONSD by ultrasound.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.
airway pressure was collected when measures ONSD by ultrasound.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.
Recording urine volume when the surgery finished.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.
Recording blood loss when the surgery finished.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.
Recording fluid volume when the surgery finished.
Measured: from the time when patients enter into operation room to the time when the surgery ending
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Mar 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (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 Laparoscopic Gynecologic SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weilian Geng, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498235
- Sponsor's protocol ID
- V2018-2
- Status last verified
- Jun 2020
- First submitted
- 8 Mar 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.
PubMed 33504329
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Double-Blind Trial A Comparative Analysis of the Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Steep Trendelenburg Position and Pneumoperitoneum for Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT03498235
- Acronym / sponsor ID
- V2018-2
- Conditions
- Laparoscopic Gynecologic Surgery
- Keywords
- sevoflurane, propofol, intracranial pressure, optic nerve sheath diameter
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Apr 2018 (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.
Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.
Detailed description
Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises.
Sevoflurane and propofol have different effects on ICP.When sevoflurane concentration >1.1 minimum alveolar concentration（MAC),ICP increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and ICP decreases.
ICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum .
Meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team Sevoflurane | Experimental | Drug: Sevoflurane |
| Team Propofol | Experimental | Drug: Propofol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status diagnosed as I or II
Key exclusion criteria (1 listed)
- neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.
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 |
|---|---|---|
| SevofluraneIn Team Sevoflurane,patients undergo sevoflurane. | Drug | Team Sevoflurane |
| PropofolIn Team Propofol ,anesthesia is maintained with propofol | Drug | Team Propofol |
Primary outcome
Changes of ultrasonographic optic nerve sheath diameter
Time frame: from the time when patients enter into operation room to the time when the surgery ending
different time including pre-anesthesia, after intubation,every 15 minutes in the first hour after beginning of surgery, every hour when one hour after surgery beginning,surgery ending.
5 secondary outcomes
Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.
Time frame: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.
Time frame: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.
Time frame: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.
Time frame: from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.
Time frame: from the time when patients enter into operation room to the time when the surgery ending
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 33504329Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sevoflurane and Propofol in people with Laparoscopic Gynecologic Surgery, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Changes of ultrasonographic optic nerve sheath diameter (time frame: from the time when patients enter into operation room to the time when the surgery ending). 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 NCT03498235, 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 23 Jun 2020.