CClinicalTrials.gg
CompletedNCT01898819Updated Jan 27, 2014

The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

An interventional study of Dexmedetomidine and saline in Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy, sponsored by Yonsei University. Completed. Open to male participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-01-27.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
Male
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Study summary

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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Conditions studied

  • Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Keywords

  • DEXMEDETOMIDINE
  • intraocular pressure
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 231 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. ASA class I-II
  2. obtaining written informed consent from the parents
  3. aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy

Exclusion criteria

Exclusion Criteria:

  1. eye surgery prevoiusly
  2. unstable angina or congestive heart failure
  3. concomittant eye disease (glaucoma, diabetic retinophaty, cataract, retinal detachment)
  4. high intraocular pressure over 30mmHg after screening test.
  5. uncontrolled hypertension (diastolic bp>110mmHg)
  6. bradycardia under 60bpm
  7. Ventricular conduction abnormality
  8. hepatic failure
  9. renal failure
  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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    dexmedetomidine

    dexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position

    Drug: Dexmedetomidine

  • Placebo comparator
    saline

    Saline infusion from same time period.

    Drug: saline

Interventions

  • DrugDexmedetomidine
  • Drugsaline
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What researchers measure

Primary outcomes

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

    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

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01898819
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 12, 2013
Start date
Jul 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Jan 27, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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