- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06685952
The Application of Ultrasonic Measurement of Optic Nerve Sheath Diameter in Liposuction Surgery
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100144
- Xu Wenli
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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. |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Optic nerve sheath diameter
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Optic nerve sheath diameter under Ultrasonic measurement
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Carotid artery flow rate
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Peak systolic velocity (PSV), End-diastolic blood flow velocity (EDV) under Ultrasonic measurement
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Carotid artery width
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Carotid artery flow rate under Ultrasonic measurement
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Bispectral index (BIS)
Time Frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Anesthesia depth measurement.
50-70 means appropriate level of sedation
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30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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OAA/S score
Time Frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Observer's assessment alert/Sedation.
1-5, 2-3 means a better outcome
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30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Liposuction swelling fluid input
Time Frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Amount of swelling anesthetic injected into fat suction area
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30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Infusion volume
Time Frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative intravenous fluid infusion
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30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Urine volume
Time Frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative urine drainage
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30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Systolic blood pressure (SBP)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative hemodynamics
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Diastolic blood pressure (DBP)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative hemodynamics
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Mean blood pressure (MBP)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative hemodynamics
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Heart rate (HR)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative hemodynamics
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Saturation of Peripheral Oxygen (SPO2)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative vital signs
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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body temperature (T)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Intraoperative vital signs
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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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
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Respiratory monitoring during surgery
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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respiratory rate (RR)
Time Frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Respiratory monitoring during surgery
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Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
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Postoperative adverse events
Time Frame: Day 1 after surgery
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Number of Participants with postoperativ headache, nausea AND vomiting (PONV)
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Day 1 after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dong Yang, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ZX2024310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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