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

NCT ID: NCT01744262

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Inhalational anesthesia group

Group Type: ACTIVE_COMPARATOR

Inhalation Anesthesia

Intervention Type: DRUG

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.

Total intravenous anesthesia group

Group Type: EXPERIMENTAL

Total intravenous anesthesia

Intervention Type: DRUG

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.

Interventions

Total 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.

Intervention Type: DRUG

Inhalation 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 24500661 (View on PubMed)

Other Identifiers

4-2011-0034

Identifier Type: -

Identifier Source: org_study_id