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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Without dexmedetomidine
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anesthesia with dexmedetomidine

Anesthesia without dexmedetomidine

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Difference in optic nerve sheath diameter
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

Difference in optic nerve sheath diameter
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.
Difference in optic nerve sheath diameter
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
Difference in optic nerve sheath diameter
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

Full Information

First Posted
May 8, 2018
Last Updated
September 12, 2018
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03529643
Brief Title
Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthesia with dexmedetomidine
Arm Type
Experimental
Arm Description
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).
Arm Title
Anesthesia without dexmedetomidine
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
With Dexmedetomidine
Intervention Description
Anesthesia with sevoflurane-remifentanil-dexmedetomidine
Intervention Type
Other
Intervention Name(s)
Without dexmedetomidine
Other Intervention Name(s)
With normal saline
Intervention Description
Anesthesia with sevoflurane-remifentanil
Primary Outcome Measure Information:
Title
Difference in optic nerve sheath diameter
Description
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
Time Frame
60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary Outcome Measure Information:
Title
Difference in optic nerve sheath diameter
Description
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.
Time Frame
30 minutes after pneumoperitoneum and steep Trendelenburg position
Title
Difference in optic nerve sheath diameter
Description
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
Time Frame
10 minutes after anesthesia induction
Title
Difference in optic nerve sheath diameter
Description
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
Time Frame
At skin closure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD,PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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