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NCT Number: NCT03529643

Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP

The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Asan medical Center

Seoul, 05505, South Korea

About this study

The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer
  • 20 years of age or older and under 80 years of age
  • Agree to participate in this study

Exclusion criteria

  • History of cerebral hemorrhage or cerebral infarction
  • < 20 years of age
  • ≥ 80 years of age
  • Glaucoma
  • Unexpected hemodynamic instability during surgery
  • Failure to measure optic nerve sheath diameter
  • Convert to open surgery

Treatment and study plan

Dexmedetomidine

Drug

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Other names: With Dexmedetomidine

Without dexmedetomidine

Other

Anesthesia with sevoflurane-remifentanil

Other names: With normal saline

Primary outcomes

  1. Difference in optic nerve sheath diameter

    Time frame: 60 minutes after pneumoperitoneum and steep Trendelenburg position

    Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy

Secondary outcomes

  1. Difference in optic nerve sheath diameter

    Time frame: 30 minutes after pneumoperitoneum and steep Trendelenburg position

    Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

  2. Difference in optic nerve sheath diameter

    Time frame: 10 minutes after anesthesia induction

    Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy

  3. Difference in optic nerve sheath diameter

    Time frame: At skin closure

    Difference between the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy: Comparison of Sevoflurane-remifentanil and Sevoflurane-remifentanil-dexmedetomidine

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
Sep 13, 2018

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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