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NCT Number: NCT02109133

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

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.

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Key information

Conditions

Robot-Assisted Laparoscopic Radical Prostatectomy

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA class I-II
  • obtaining written informed consent from the parents
  • aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy

Exclusion criteria

  • eye surgery previously
  • unstable angina or congestive heart failure
  • concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
  • high intraocular pressure over 30mmHg after screening test.
  • uncontrolled hypertension (diastolic bp>110mmHg)
  • coagulopathy
  • asthma
  • hepatic failure
  • renal failure(creatinine clearance < 30 ml/min)
  • drug hyperactivity
  • neurological or psychiatric illnesses
  • mental retardation
  • patients who can't read the consent form due to illiterate or foreigner
  • previous malignant hyperthermia Hx
  • drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
  • BMI > 30kg/m2

Treatment and study plan

deep neuromuscular blockade

Procedure

deep neuromuscular blockade using rocuronium and reverse with sugammadex

moderate neuromuscular blockade

Procedure

moderate neuromuscular blockade using atracurium and reverse with neostigmine

Rocuronium

Drug

Sugammadex

Drug

Atracurium

Drug

Neostigmine

Drug

Primary outcomes

  1. Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade

    Time frame: Maximum 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 outcomes

  1. Overall Surgical Condition

    Time frame: At 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.

Other outcomes

  1. Post-operative Nausea

    Time frame: During 24hours after operation

  2. Incidence of Residual Neuromuscular Blockade

    Time frame: During 24hours after operation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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