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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01898819

Enrollment

Registered

2013-07-12

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Keywords

DEXMEDETOMIDINE, intraocular pressure

Brief 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.

Interventions

DRUGDexmedetomidine

DRUGsaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 80 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy.	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026