Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy

Other Surgical Procedures Clinical Trial

Official title:

Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516566
• Other study ID #: AsanMC
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: November 30, 2015
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Description:

Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

• Patients who have cerebrovascular disease or history of cerebrovascular disease

• Patients who are younger than 20 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Other Surgical Procedures

Intervention

Other:
• PEEP
Mechanical ventilation with PEEP 8 cmH2O

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve sheath diameter		intraoperative	No
Secondary	Peak airway pressure		intraoperative	No
Secondary	Arterial blood pressure		intraoperative	No
Secondary	Heart rate		intraoperative	No
Secondary	Arterial carbon dioxide tension		intraoperative	No