Optic Nerve Sheath DiameterNCT06685952
The Application of Ultrasonic Measurement of Optic Nerve Sheath Diameter in Liposuction Surgery
An observational study of Optic Nerve Sheath Diameter, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College at 1 site in China.
Trial summary
The main purpose of this study is to investigate the effect of changes in Optic Nerve Sheath Diameter (ONSD) measured at different operating position during Liposuction Surgery. Optic nerve sheath diameter (ONSD) has been shown to be a noninvasive indicator for monitoring intracranial pressure changes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Optic Nerve Sheath Diameter
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 26 May 2025
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients who will undergo liposuction surgery under sedation and sedative anesthesia. Fat suction areas can be the abdomen, lower back, limbs and other parts.
Who may be able to join
- Patients aged 18-50 years, undergoing liposuction surgery.
- American Society of Anesthesiologists (ASA) physical status Ⅰ and Ⅱ.
- Voluntary participation and signed an informed consent form.
Who cannot join
- Uncontrolled hypertension, diabetes.
- High nearsightedness or farsightedness, recent eye surgery, and other conditions in which ONSD cannot be measured.
- Moderate to severe obstructive sleep apnea syndrome was present before surgery.
- History of severe mental or neurological diseases, drug or psychotropic drug abuse.
- Cognitive dysfunction or inability to communicate.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to investigate the effect of changes in Optic Nerve Sheath Diameter (ONSD) measured at different operating position during Liposuction Surgery.
Optic nerve sheath diameter (ONSD) has been shown to be a noninvasive indicator for monitoring intracranial pressure changes.
The use of anesthetic drugs will reduce the intracranial pressure. However, prone position and large fluid infusion can still lead to increased intracranial pressure.
The investigators hypothesized that during sedation and analgesia anesthesia, patients in prone position had higher ONSD.
Read the detailed description
Liposuction is a common type of surgery in plastic surgery. In this type of surgery, the position is often changed from prone to supine. Different surgical positions, especially excessive flexion or rotation of the neck, can cause compression of the internal jugular vein, resulting in blocked cerebral venous return and resulting in increased intracranial pressure. Sedation and analgesia anesthesia are often used in liposuction surgery to provide the patient with an appropriate depth of anesthesia, preserve the patient's independent breathing, and can wake the patient during the operation to complete the position switch independently. Dexmedetomidine is a commonly used drug for sedation and analgesia anesthesia. Studies have reported that dexmedetomidine can be used to control intracranial pressure in special surgical positions by reducing cerebral metabolic rate, maintaining cerebral oxygen supply and demand balance, shrinking cerebral vessels and other functions.
Other studies have suggested that IOP increases during prone anesthesia, despite the effect of anesthetic drugs on lowering IOP. IOP, choroidal thickness, and optic nerve diameter also increased in normally awake patients in prone position. Optic nerve sheath diameter (ONSD) has been shown to be a noninvasive indicator of intracranial pressure changes and an independent factor of mortality, poor prognosis, and severity of traumatic brain injury. ONSD measurement is often used in laparoscopic surgery under general anesthesia to observe the effect of elevated CO2 in pneumoperitoneum on IOP. The changes of intracranial pressure were evaluated by ONSD when the head was low and the feet were high.
At present, there are no studies to observe the change of ONSD at different positions during Liposuction Surgery with sedation and analgesia.
The investigators hypothesized that during sedation and analgesia anesthesia, patients in prone position had higher ONSD.
This is an observational study. They were divided into two groups according to the operation, prone group and supine group.T0 awake, T1 30min after sedation and analgesia, T2 30 minutes after T1， T3 end of the operation. Record Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate. Statistically significant differences were assessed.
The incidence of headache, nausea, vomiting and delirium were observed within 24 hours after operation.
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Optic nerve sheath diameter, Sedation and analgesia anesthesia, Liposuction surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prone position group | Sedation and analgesia anesthesia will be administered after the prone position. All patients will receive standardized sedation and analgesia anesthesia with 1ug/kg sufentanil，1ug/kg/h dexmedetomidine，1mg/h midazolam，0.05-0.1ug/kg/min remifentanil. And adjust the drug speed according to the patient's respiratory rate, BIS changes. Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate will be measured at four time points respectively. | |
| Supine group | Sedation and analgesia anesthesia will be administered after the supine position. All patients will receive standardized sedation and analgesia anesthesia with 1ug/kg sufentanil，1ug/kg/h dexmedetomidine，1mg/h midazolam，0.05-0.1ug/kg/min remifentanil. And adjust the drug speed according to the patient's respiratory rate, BIS changes. Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate will be measured at four time points respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Optic nerve sheath diameter under Ultrasonic measurement
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Secondary outcomes (16)
Carotid artery flow rate
Peak systolic velocity (PSV), End-diastolic blood flow velocity (EDV) under Ultrasonic measurement
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Carotid artery width
Carotid artery flow rate under Ultrasonic measurement
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Bispectral index (BIS)
Anesthesia depth measurement. 50-70 means appropriate level of sedation
Measured: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
OAA/S score
Observer's assessment alert/Sedation. 1-5, 2-3 means a better outcome
Measured: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Liposuction swelling fluid input
Amount of swelling anesthetic injected into fat suction area
Measured: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Infusion volume
Intraoperative intravenous fluid infusion
Measured: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Urine volume
Intraoperative urine drainage
Measured: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Systolic blood pressure (SBP)
Intraoperative hemodynamics
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Diastolic blood pressure (DBP)
Intraoperative hemodynamics
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Mean blood pressure (MBP)
Intraoperative hemodynamics
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Heart rate (HR)
Intraoperative hemodynamics
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Saturation of Peripheral Oxygen (SPO2)
Intraoperative vital signs
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
body temperature (T)
Intraoperative vital signs
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
The partial pressure of end-tidal carbon dioxide (PetCO2)
Respiratory monitoring during surgery
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
respiratory rate (RR)
Respiratory monitoring during surgery
Measured: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Postoperative adverse events
Number of Participants with postoperativ headache, nausea AND vomiting (PONV)
Measured: Day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start19 Nov 2024
- Primary completion25 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Wenli, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Investigators
- Dong Yang, Study chair, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685952
- Sponsor's protocol ID
- ZX2024310
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Ultrasonic Measurement of Optic Nerve Sheath Diameter in Liposuction Surgery
- ClinicalTrials.gov ID
- NCT06685952
- Acronym / sponsor ID
- ZX2024310
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Optic nerve sheath diameter, Sedation and analgesia anesthesia, Liposuction surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 13 Nov 2024 (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 main purpose of this study is to investigate the effect of changes in Optic Nerve Sheath Diameter (ONSD) measured at different operating position during Liposuction Surgery.
Optic nerve sheath diameter (ONSD) has been shown to be a noninvasive indicator for monitoring intracranial pressure changes.
The use of anesthetic drugs will reduce the intracranial pressure. However, prone position and large fluid infusion can still lead to increased intracranial pressure.
The investigators hypothesized that during sedation and analgesia anesthesia, patients in prone position had higher ONSD.
Detailed description
Liposuction is a common type of surgery in plastic surgery. In this type of surgery, the position is often changed from prone to supine. Different surgical positions, especially excessive flexion or rotation of the neck, can cause compression of the internal jugular vein, resulting in blocked cerebral venous return and resulting in increased intracranial pressure. Sedation and analgesia anesthesia are often used in liposuction surgery to provide the patient with an appropriate depth of anesthesia, preserve the patient's independent breathing, and can wake the patient during the operation to complete the position switch independently. Dexmedetomidine is a commonly used drug for sedation and analgesia anesthesia. Studies have reported that dexmedetomidine can be used to control intracranial pressure in special surgical positions by reducing cerebral metabolic rate, maintaining cerebral oxygen supply and demand balance, shrinking cerebral vessels and other functions.
Other studies have suggested that IOP increases during prone anesthesia, despite the effect of anesthetic drugs on lowering IOP. IOP, choroidal thickness, and optic nerve diameter also increased in normally awake patients in prone position. Optic nerve sheath diameter (ONSD) has been shown to be a noninvasive indicator of intracranial pressure changes and an independent factor of mortality, poor prognosis, and severity of traumatic brain injury. ONSD measurement is often used in laparoscopic surgery under general anesthesia to observe the effect of elevated CO2 in pneumoperitoneum on IOP. The changes of intracranial pressure were evaluated by ONSD when the head was low and the feet were high.
At present, there are no studies to observe the change of ONSD at different positions during Liposuction Surgery with sedation and analgesia.
The investigators hypothesized that during sedation and analgesia anesthesia, patients in prone position had higher ONSD.
This is an observational study. They were divided into two groups according to the operation, prone group and supine group.T0 awake, T1 30min after sedation and analgesia, T2 30 minutes after T1， T3 end of the operation. Record Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate. Statistically significant differences were assessed.
The incidence of headache, nausea, vomiting and delirium were observed within 24 hours after operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position group | – | –Sedation and analgesia anesthesia will be administered after the prone position. All patients will receive standardized sedation and analgesia anesthesia with 1ug/kg sufentanil，1ug/kg/h dexmedetomidine，1mg/h midazolam，0.05-0.1ug/kg/min remifentanil. And adjust the drug speed according to the patient's respiratory rate, BIS changes. Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate will be measured at four time points respectively. |
| Supine group | – | –Sedation and analgesia anesthesia will be administered after the supine position. All patients will receive standardized sedation and analgesia anesthesia with 1ug/kg sufentanil，1ug/kg/h dexmedetomidine，1mg/h midazolam，0.05-0.1ug/kg/min remifentanil. And adjust the drug speed according to the patient's respiratory rate, BIS changes. Optic nerve sheath diameter (ONSD), carotid artery flow rate, Bispectral index (BIS), liposuction swelling fluid input, infusion volume, end-expiratory carbon dioxide, mean arterial pressure, heart rate, peripheral oxygen saturation, body temperature and respiratory rate will be measured at four time points respectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients who will undergo liposuction surgery under sedation and sedative anesthesia. Fat suction areas can be the abdomen, lower back, limbs and other parts.
Key inclusion criteria (3 listed)
- Patients aged 18-50 years, undergoing liposuction surgery.
- American Society of Anesthesiologists (ASA) physical status Ⅰ and Ⅱ.
- Voluntary participation and signed an informed consent form.
Key exclusion criteria (5 listed)
- Uncontrolled hypertension, diabetes.
- High nearsightedness or farsightedness, recent eye surgery, and other conditions in which ONSD cannot be measured.
- Moderate to severe obstructive sleep apnea syndrome was present before surgery.
- History of severe mental or neurological diseases, drug or psychotropic drug abuse.
- Cognitive dysfunction or inability to communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optic nerve sheath diameter
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Optic nerve sheath diameter under Ultrasonic measurement
16 secondary outcomes
Carotid artery flow rate
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Carotid artery width
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Bispectral index (BIS)
Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
OAA/S score
Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Liposuction swelling fluid input
Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Infusion volume
Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Urine volume
Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Systolic blood pressure (SBP)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Diastolic blood pressure (DBP)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Mean blood pressure (MBP)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Heart rate (HR)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Saturation of Peripheral Oxygen (SPO2)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
body temperature (T)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
The partial pressure of end-tidal carbon dioxide (PetCO2)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
respiratory rate (RR)
Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Postoperative adverse events
Time frame: Day 1 after surgery
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 30 Sep 2025.
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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.
Dong Yang study chair
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve Sheath Diameter, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 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 3 inclusion and 5 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 30 Sep 2025. 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.
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?
Optic nerve sheath diameter (time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of 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 30 Sep 2025.