The Application of Ultrasonic Measurement of Optic Nerve Sheath Diameter in Liposuction Surgery
1 other identifier
observational
55
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2024
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedStudy Start
First participant enrolled
November 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2025
CompletedSeptember 30, 2025
September 1, 2025
6 months
November 7, 2024
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Optic nerve sheath diameter
Optic nerve sheath diameter under Ultrasonic measurement
Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Secondary Outcomes (16)
Carotid artery flow rate
Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Carotid artery width
Enter the operating room, 30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Bispectral index (BIS)
30min and 60min after sedative AND analgesic anaesthesia, end of surgery
OAA/S score
30min and 60min after sedative AND analgesic anaesthesia, end of surgery
Liposuction swelling fluid input
30min and 60min after sedative AND analgesic anaesthesia, end of surgery
- +11 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xu Wenli
Beijing, Beijing Municipality, 100144, China
Study Officials
- STUDY CHAIR
Dong Yang
Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 13, 2024
Study Start
November 19, 2024
Primary Completion
May 25, 2025
Study Completion
May 26, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09