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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529643
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Young-Kug Kim, Asan Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Dexmedetomidine Other: Without dexmedetomidine Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Actual Study Start Date : May 24, 2018
Actual Primary Completion Date : August 16, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anesthesia with dexmedetomidine

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Dexmedetomidine :Continuous infusion of dexmedetomidine with loading dose of 1.0 μg/kg (0.25 ml/kg) for 10 minutes, then followed by maintenance dose of 0.4 µg/kg/hr (0.1 ml/kg/hr).

Drug: Dexmedetomidine
Anesthesia with sevoflurane-remifentanil-dexmedetomidine
Other Name: With Dexmedetomidine

Placebo Comparator: Anesthesia without dexmedetomidine

Anesthesia with sevoflurane-remifentanil

Normal saline :Continuous infusion of normal saline with loading dose (0.25 ml/kg) for 10 minutes, then followed by maintenance dose (0.1 ml/kg/hr).

Other: Without dexmedetomidine
Anesthesia with sevoflurane-remifentanil
Other Name: With normal saline




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529643


Locations
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Korea, Republic of
Asan medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young-Kug Kim, MD,PhD Asan Medical Center
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Responsible Party: Young-Kug Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03529643    
Other Study ID Numbers: 20180523
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action