Clinical trial NCT03016234: IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery
Official title: Intraocular Pressure Changes During Laparoscopic Colorectal Surgery: Propofol Versus Desflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: intraocular pressure
trendelenburg position
pneumoperitoneum
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is aimed to evaluate how intraocular pressure (IOP) is changed depending on surgical position (Trendelenburg versus reverse Trendelenburg) in the same patient and to compare the effects of different anesthetics on IOP (desflurane versus propofol) in patients undergoing laparoscopic colorectal surgery. The study design is a double-blind randomized controlled trial. The patients were randomly assigned to desflurane or propofol administrated groups and all patient are administered intravenous remifentanil continuously as adjuvant analgesics during anesthesia. For this study 50 to 80-year-old patients undergoing laparoscopic colorectal surgery without eye disease were enrolled. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP (using a Tono-pen® Avia tonometer) on both eyes were measured at defined intervals during the procedure.

Detailed description: Perioperative visual loss is a rare but devastating complication associated with certain type of operative procedures. Laparoscopic or robotic surgeries for colorectal cancer, prostate cancer and diseases of the female genital organs in the pelvic cavity are performed in a steep Trendelenburg position and pneumoperitoneum, which increases the intraocular pressure (IOP) by 13-26 mmHg compared with the preoperative IOP value. High intraocular pressure is believed to correlate with decreased perfusion to the optic nerve, and thus could lead to ischemic optic neuropathy. The objective of the study is to test which anesthetic agent (desflurane or propofol) can attenuate the changes in IOP during laparoscopic colorectal surgery and identify correlated parameters. Fifty patients (30-80 years; American Society of Anesthesiologists' physical status 1-2) scheduled for laparoscopic colorectal surgery will be enrolled and allocated randomly into two groups (group D and group P). After measurement of initial IOP with topical opthalmic anesthetics, general anesthesia will be induced with pentothal sodium 5-6mg/kg (group D) or propofol (group P) 2-2.5mg/kg. After administration of muscle relaxant and intubation, intraocular pressure will be measured and anesthesia will be maintained with desflurane (group D) or propofol (group P) and all patients will be administered intravenous remifentanil concurrently during anesthesia. During anesthesia, IOP will be measured at different patient positions. At the time of each IOP measurements, the following data set will be collected: mean arterial pressure (MAP), End tidal carbon dioxide (EtCO2), peak inspiratory pressure (PIP).

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic colorectal surgery American society of anesthesiologist physical status class I or II

Exclusion Criteria:

* opthalmic disease or previously undergone opthalmic surgery, uncontrolled hypertension, arrythmia, psychiatric disorder, uncontrolled obstructive lung disease

Primary outcomes:
measure: changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
timeFrame: before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
Secondary outcomes:
measure: changes in mean arterial pressure (MAP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
timeFrame: before anesthesia induction, immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
measure: changes in end tidal carbon dioxide in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
timeFrame: immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
measure: changes in peak airway pressure in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.
timeFrame: immediately after intubation, after pneumoperitoneum, 30 minutes after head down and right tilt position, 10 minutes after head up and right tilt, 30 minutes after head down and right tilt and 5 minutes before extubation
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Saint Vincent's Hospital, Korea
state: Gyonggido
Study officials:
affiliation: Saint Vincent's Hospital, Korea
name: Kwon hui Seo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joo J, Koh H, Lee K, Lee J. Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure and Ocular Perfusion Pressure during Laparoscopic Surgery in a Steep Trendelenburg Position: Prospective, Randomized, Double-Blinded Study. J Korean Med Sci. 2016 Jun;31(6):989-96. doi: 10.3346/jkms.2016.31.6.989. Epub 2016 Apr 6.