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

NCT03529643 | Completed DMC

• 1 other identifier: 20180523
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  60 minutes after pneumoperitoneum and steep Trendelenburg position

Secondary Outcomes (3)

• Difference in optic nerve sheath diameter

  30 minutes after pneumoperitoneum and steep Trendelenburg position

• Difference in optic nerve sheath diameter

  10 minutes after anesthesia induction

• Difference in optic nerve sheath diameter

  At skin closure

Study Arms (2)

Anesthesia with dexmedetomidine

EXPERIMENTAL

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 without dexmedetomidine

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine DRUG

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Also known as: With Dexmedetomidine

Anesthesia with dexmedetomidine

Without dexmedetomidine OTHER

Anesthesia with sevoflurane-remifentanil

Also known as: With normal saline

Anesthesia without dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Young-Kug Kim, MD,PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 18, 2018
• Study Start: May 24, 2018
• Primary Completion: August 16, 2018
• Study Completion: August 22, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)