Uterus MyomaNCT03701529
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
A study testing Sevoflurane and Propofol in people with Uterus Myoma and Uterine Cancer, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterus Myoma, Uterine Cancer
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2018to 16 Sep 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
Who cannot join
- history of brain hemorrhage or brain infarction
- liver disease or end stage renal disease
- glaucoma or any signs of increased intraocular pressure
- combined wtih other types of operation
- patient refusal
- weight less than 40 kg or over 100 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.
Read the detailed description
Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.
Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.
- Conditions
- Uterus Myoma, Uterine Cancer
- Being tested
- Sevoflurane, Propofol
- Medical subject headings
- Myofibroma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called sevoflurane anesthesia
1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
PropofolDrug
Also called propofol anesthesia
2-5 mcg/ml of propofol is used for maintenance of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | 1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia. Receives: Drug: Sevoflurane |
| Propofol | Active comparator | 2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference of optic nerve sheath diameter
optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)
Measured: During the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start15 Oct 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterus MyomaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Choi Eun-Mi, Professor, Study chair, Kangnam Sungshim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701529
- Sponsor's protocol ID
- 2018-09-004
- Status last verified
- Jan 2020
- First submitted
- 8 Oct 2018
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery
- ClinicalTrials.gov ID
- NCT03701529
- Acronym / sponsor ID
- 2018-09-004
- Conditions
- Uterus Myoma, Uterine Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 10 Oct 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.
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.
Detailed description
Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.
Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: Sevoflurane1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia. |
| Propofol | Active comparator | Drug: Propofol2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
Key exclusion criteria (6 listed)
- history of brain hemorrhage or brain infarction
- liver disease or end stage renal disease
- glaucoma or any signs of increased intraocular pressure
- combined wtih other types of operation
- patient refusal
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 |
|---|---|---|
| SevofluraneAlso: sevoflurane anesthesia1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia. | Drug | Sevoflurane |
| PropofolAlso: propofol anesthesia2-5 mcg/ml of propofol is used for maintenance of anesthesia. | Drug | Propofol |
Primary outcome
difference of optic nerve sheath diameter
Time frame: During the operation.
optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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.
Choi Eun-Mi, Professor study chair
Kangnam Sungshim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane and Propofol in people with Uterus Myoma and Uterine Cancer, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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 6 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: finished, as of the sponsor's last update on 4 Sep 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
difference of optic nerve sheath diameter (time frame: During the operation.). 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 4 Sep 2020.