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

NCT01744262 | Completed DMC

• 1 other identifier: 4-2011-0034
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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

Keywords

intraocular pressure, total intravenous anesthesia, laparoscopic prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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)

  Changes in intraocular pressure during pneumoperitoneum in the steep Trendelenburg position

Study Arms (2)

Inhalational anesthesia group

ACTIVE COMPARATOR

Drug: Inhalation Anesthesia

Total intravenous anesthesia group

EXPERIMENTAL

Drug: Total intravenous anesthesia

Interventions

Total intravenous anesthesia 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.

Total intravenous anesthesia group

Inhalation Anesthesia 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.

Inhalational anesthesia group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Related Publications (1)

• 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.

  PMID: 24500661 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 17, 2016

Record last verified: 2016-08