NCT06685952

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

November 7, 2024

Last Update Submit

September 29, 2025

Conditions

Keywords

Optic nerve sheath diameterSedation and analgesia anesthesiaLiposuction surgery

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

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

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

Location

Study Officials

  • Dong Yang

    Plastic Surgery Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College

    STUDY CHAIR

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

Locations