Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic ProstatectomyNCT01898819
The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
A study testing Dexmedetomidine and saline in people with Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
- What is being tested?
- Dexmedetomidine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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.
- Conditions
- Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
- Being tested
- Dexmedetomidine, saline
- Keywords
- DEXMEDETOMIDINE, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
salineDrug
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | dexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position Receives: Drug: Dexmedetomidine |
| saline | Placebo comparator | Saline infusion from same time period. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change of intraocular pressure from T0 to T11 for 60mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic ProstatectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898819
- Sponsor's protocol ID
- 4-2013-0195
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2013
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine in Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01898819
- Acronym / sponsor ID
- 4-2013-0195
- Conditions
- Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
- Keywords
- DEXMEDETOMIDINE, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidinedexmedetomidine infusion from beginning of the anesthesia to just before returning to horizontal position |
| saline | Placebo comparator | Drug: salineSaline infusion from same time period. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I-II
- obtaining written informed consent from the parents
- aged 20-70 years who were undergoing robot- assited laparoscopic prostatectomy
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | dexmedetomidine |
| saline | Drug | saline |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
Related trials for Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy
RecruitingObservational study
Effect Of Trendelenburg Position And Pneumoperitoneum On Optic Nerve Sheath Diameter In Robot-Assisted Prostatectomy
Prostate Cancer, Optic Nerve Sheath Diameter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and saline in people with Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of dexmedetomidine in intraocular pressure during robot-assisted laparoscopic prostatectomy. (time frame: change of intraocular pressure from T0 to T11 for 60mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2014.