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

Completed

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

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100144
        • Xu Wenli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Carotid artery flow rate under Ultrasonic measurement
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
Anesthesia depth measurement. 50-70 means appropriate level of sedation
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
Observer's assessment alert/Sedation. 1-5, 2-3 means a better outcome
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
Amount of swelling anesthetic injected into fat suction area
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
Intraoperative intravenous fluid infusion
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
Intraoperative urine drainage
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
Intraoperative hemodynamics
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
Intraoperative hemodynamics
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
Intraoperative hemodynamics
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
Intraoperative hemodynamics
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
Intraoperative vital signs
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
Intraoperative vital signs
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 monitoring during surgery
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
Respiratory monitoring during surgery
Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Postoperative adverse events
Time Frame: Day 1 after surgery
Number of Participants with postoperativ headache, nausea AND vomiting (PONV)
Day 1 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Dong Yang, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Actual)

May 25, 2025

Study Completion (Actual)

May 26, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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