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A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01744262
Enrollment
66
Registered
2012-12-06
Start date
2011-05-31
Completion date
2012-03-31
Last updated
2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy

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.

Interventions

DRUGInhalation Anesthesia

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.

DRUGTotal intravenous anesthesia

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

1. ASA class 1 or 2 2. Adults over the age of 20 and under 70 3. Patients undergoing robot-assisted laparoscopic radical prostatectomy 4. Patients that have given informed consent

Exclusion criteria

1. Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment) 2. Patients with history of ophthalmic surgery 3. Patients with high baseline intraocular pressure (over 30 mmHg) 4. Patients with active cardiac conditions (unstable angina, congestive heart failure) 5. Patients with uncontrolled hypertension (diastolic blood pressure \> 110 mmHg) 6. Patients with history of allergic reactions to propofol 7. Illiterate patients

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressureChanges in intraocular pressure during pneumoperitoneum in the steep Trendelenburg positionBefore 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026