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NCT Number: NCT03701529

Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.

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Key information

Conditions

Uterus Myoma Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangnam Sungshim Hospital

Seoul, South Korea

About this study

Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.

Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy

Exclusion criteria

  • history of brain hemorrhage or brain infarction
  • liver disease or end stage renal disease
  • glaucoma or any signs of increased intraocular pressure
  • combined wtih other types of operation
  • patient refusal
  • weight less than 40 kg or over 100 kg

Treatment and study plan

Sevoflurane

Drug

1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.

Other names: sevoflurane anesthesia

Propofol

Drug

2-5 mcg/ml of propofol is used for maintenance of anesthesia.

Other names: propofol anesthesia

Primary outcomes

  1. difference of optic nerve sheath diameter

    Time frame: During the operation.

    optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2018
Registry last updated
Sep 4, 2020

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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