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

Not Applicable

Completed

• Conditions: Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
• Interventions: Drug: saline; Drug: Dexmedetomidine

• Registration Number: NCT01898819
• 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 timeds of pneumoperitoneum. Threrefore we decided to evaluate the effect of dexmedetomidine in intraocular pressure during roboti-assisted laparoscopic radical prostatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	saline	Saline infusion from same time period.
dexmedetomidine	Dexmedetomidine	dexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position

Primary Outcome Measures

Name	Time	Method
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