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

January 23, 2014 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change of intraocular pressure from T0 to T11 for 60mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (ESTIMATE)

July 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Steep Trendelenburg Position With Penumoperitoneum in Robot Assisted Laparoscopic Prostatectomy

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe