The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
1 other identifier
interventional
70
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 9, 2013
CompletedFirst Posted
Study publicly available on registry
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 27, 2014
January 1, 2014
5 months
July 9, 2013
January 23, 2014
Conditions
Keywords
Outcome Measures
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
change of intraocular pressure from T0 to T11 for 60mins
Study Arms (2)
dexmedetomidine
EXPERIMENTALdexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position
saline
PLACEBO COMPARATORSaline infusion from same time period.
Interventions
Eligibility Criteria
You may qualify if:
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2013
First Posted
July 12, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 27, 2014
Record last verified: 2014-01