A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total intravenous anesthesia
Inhalation Anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy
Eligibility Criteria
Inclusion Criteria:
- ASA class 1 or 2
- Adults over the age of 20 and under 70
- Patients undergoing robot-assisted laparoscopic radical prostatectomy
- Patients that have given informed consent
Exclusion Criteria:
- Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment)
- Patients with history of ophthalmic surgery
- Patients with high baseline intraocular pressure (over 30 mmHg)
- Patients with active cardiac conditions (unstable angina, congestive heart failure)
- Patients with uncontrolled hypertension (diastolic blood pressure > 110 mmHg)
- Patients with history of allergic reactions to propofol
- Illiterate patients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Inhalational anesthesia group
Total intravenous anesthesia group
Arm Description
Outcomes
Primary Outcome Measures
Intraocular pressure
Before induction of anesthesia (T0), 5 minutes after induction of anesthesia (T1), 5 minutes after pneumoperitoneum (T2), 30 minutes after steep Trendelenburg position with pneumoperitoneum (T3), 5 minutes after returning to horizontal position with pneumoperitoneum (T4), 5 minutes after desufflation (T5), 5 minutes after awakening in the operating room (T6), 60 minutes after awakening in the recovery room (T7), 24 hours after the operation (T9)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01744262
Brief Title
A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the past decade and has widely replaced conventional open prostatectomy in many institutions due to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay. However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation, which leads to increased intraocular pressure (IOP). In particular, robot-assisted laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position and often prolonged insufflation times, which is known to effect the increase in IOP during surgery and may result in ophthalmic complications such as postoperative vision loss (POVL). The majority of patients undergoing RALRP is old aged and often present with comorbidities. Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having undiagnosed glaucoma is also increased, and therefore methods to prevent such complications are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous humour outflow to some extent. Among these agents, propofol has been reported to be more effective than other inhalational anesthetics in decreasing IOP. The goal of this prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide pneumoperitoneum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhalational anesthesia group
Arm Type
Active Comparator
Arm Title
Total intravenous anesthesia group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Total intravenous anesthesia
Intervention Description
Anesthesia induction with intravenous propofol (effect site concentration 2.5 µg/mL) and remifentanil (effect site concentration 3 ng/mL) using target controlled infusion (TCI). Anesthesia maintenance with propofol effect site concentration 1.5~4 µg/mL and remifentanil effect site concentration 2~5 ng/mL.
Intervention Type
Drug
Intervention Name(s)
Inhalation Anesthesia
Intervention Description
Anesthesia induction with intravenous propofol bolus of 1.5~2.5 mg/kg and remifentanil (effect site concentration 3 ng/mL)using target controlled infusion (TCI). Anesthesia maintenance with sevoflurane 1.5~2.0 % and remifentanil effect site concentration 2~5 ng/mL.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Before induction of anesthesia (T0), 5 minutes after induction of anesthesia (T1), 5 minutes after pneumoperitoneum (T2), 30 minutes after steep Trendelenburg position with pneumoperitoneum (T3), 5 minutes after returning to horizontal position with pneumoperitoneum (T4), 5 minutes after desufflation (T5), 5 minutes after awakening in the operating room (T6), 60 minutes after awakening in the recovery room (T7), 24 hours after the operation (T9)
Time Frame
Changes in intraocular pressure during pneumoperitoneum in the steep Trendelenburg position
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA class 1 or 2
Adults over the age of 20 and under 70
Patients undergoing robot-assisted laparoscopic radical prostatectomy
Patients that have given informed consent
Exclusion Criteria:
Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment)
Patients with history of ophthalmic surgery
Patients with high baseline intraocular pressure (over 30 mmHg)
Patients with active cardiac conditions (unstable angina, congestive heart failure)
Patients with uncontrolled hypertension (diastolic blood pressure > 110 mmHg)
Patients with history of allergic reactions to propofol
Illiterate patients
12. IPD Sharing Statement
Citations:
PubMed Identifier
24500661
Citation
Yoo YC, Shin S, Choi EK, Kim CY, Choi YD, Bai SJ. Increase in intraocular pressure is less with propofol than with sevoflurane during laparoscopic surgery in the steep Trendelenburg position. Can J Anaesth. 2014 Apr;61(4):322-9. doi: 10.1007/s12630-014-0112-2. Epub 2014 Feb 4.
Results Reference
derived
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A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy
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