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Completed

NCT Number: NCT01898819

The Effect of Dexmedetomidine in Intraocular Pressure During 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 timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.

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Key information

Conditions

Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Age range

20 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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 20-70 years who were undergoing robot- assited laparoscopic prostatectomy

Exclusion criteria

  • eye surgery prevoiusly
  • unstable angina or congestive heart failure
  • concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment)
  • high intraocular pressure over 30mmHg after screening test.
  • uncontrolled hypertension (diastolic bp>110mmHg)
  • bradycardia under 60bpm
  • Ventricular conduction abnormality
  • hepatic failure
  • renal failure
  • drug hyperactivity
  • neurological or psychiatric illnesses
  • mental retardation
  • patients who can't read the consent form due to illiterate or foreigner

Treatment and study plan

Dexmedetomidine

Drug

Saline

Drug

Primary outcomes

  1. Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy.

    Time frame: change of intraocular pressure from T0 to T11 for 60mins

    T0: Pre-induciton T1: 5min after anesthesia induction T2: 5 min after establish pneumoperitoneum T3: 15min after steep trendelenburg position T4: 30min after steep trendelenburg position T5: 45min after steep trendelenburg T6: 60min after steep trendelenburg T7: 75min after steep trendelenburg T8: 5min after returning to horizontal position T9: operation end T10: 5min after tracheal extubation T11: 60min after tracheal extubation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2013
Registry last updated
Jan 27, 2014

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

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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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