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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Dexmedetomidine; Other: Without dexmedetomidine

• Registration Number: NCT03529643
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-05-24
• Primary Completion: 2018-08-16
• Study Completion: 2018-08-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthesia with dexmedetomidine	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).
Anesthesia without dexmedetomidine	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).

Primary Outcome Measures

Name	Time	Method
Difference in optic nerve sheath diameter	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

Name	Time	Method
Difference in optic nerve sheath diameter	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

Trial Locations

Locations (1)

Asan medical Center; 🇰🇷 Seoul, Korea, Republic of