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Completed

NCT Number: 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Xu Wenli

Beijing, Beijing Municipality, 100144, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Carotid artery flow rate

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Peak systolic velocity (PSV), End-diastolic blood flow velocity (EDV) under Ultrasonic measurement

  2. Carotid artery width

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Carotid artery flow rate under Ultrasonic measurement

  3. Bispectral index (BIS)

    Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Anesthesia depth measurement. 50-70 means appropriate level of sedation

  4. OAA/S score

    Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Observer's assessment alert/Sedation. 1-5, 2-3 means a better outcome

  5. Liposuction swelling fluid input

    Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Amount of swelling anesthetic injected into fat suction area

  6. Infusion volume

    Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative intravenous fluid infusion

  7. Urine volume

    Time frame: 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative urine drainage

  8. Systolic blood pressure (SBP)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative hemodynamics

  9. Diastolic blood pressure (DBP)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative hemodynamics

  10. Mean blood pressure (MBP)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative hemodynamics

  11. Heart rate (HR)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative hemodynamics

  12. Saturation of Peripheral Oxygen (SPO2)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative vital signs

  13. body temperature (T)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Intraoperative vital signs

  14. 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 monitoring during surgery

  15. respiratory rate (RR)

    Time frame: Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

    Respiratory monitoring during surgery

  16. Postoperative adverse events

    Time frame: Day 1 after surgery

    Number of Participants with postoperativ headache, nausea AND vomiting (PONV)

Sponsors and collaborators

Lead sponsor

The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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