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The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Not Applicable
Completed
Conditions
Robot-Assisted Laparoscopic Radical Prostatectomy
Interventions
Procedure: deep neuromuscular blockade
Procedure: moderate neuromuscular blockade
Registration Number
NCT02109133
Lead Sponsor
Yonsei University
Brief Summary

Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
67
Inclusion Criteria
  1. ASA class I-II
  2. obtaining written informed consent from the parents
  3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy
Exclusion Criteria
  1. eye surgery previously
  2. unstable angina or congestive heart failure
  3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
  4. high intraocular pressure over 30mmHg after screening test.
  5. uncontrolled hypertension (diastolic bp>110mmHg)
  6. coagulopathy
  7. asthma
  8. hepatic failure
  9. renal failure(creatinine clearance < 30 ml/min)
  10. drug hyperactivity
  11. neurological or psychiatric illnesses
  12. mental retardation
  13. patients who can't read the consent form due to illiterate or foreigner
  14. previous malignant hyperthermia Hx
  15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
  16. BMI > 30kg/m2

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Deep neuromuscular blockadedeep neuromuscular blockadeDeep neuromuscular blockade
moderate neuromuscular blockademoderate neuromuscular blockademoderate neuromuscular blockade
Deep neuromuscular blockadeRocuroniumDeep neuromuscular blockade
Deep neuromuscular blockadeSugammadexDeep neuromuscular blockade
moderate neuromuscular blockadeNeostigminemoderate neuromuscular blockade
moderate neuromuscular blockadeAtracuriummoderate neuromuscular blockade
Primary Outcome Measures
NameTimeMethod
Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular BlockadeMaximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position

maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade

Secondary Outcome Measures
NameTimeMethod
Overall Surgical ConditionAt the end of the Steep trendelenburg position, an average of 1 hour

overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

🇰🇷

Seoul, Korea, Republic of

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