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Completed

NCT Number: NCT03016234

IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery

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.

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Key information

Conditions

Intraocular Pressure Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Vincent's Hospital, Korea

Suwon, Gyonggido, 16247, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with pentothal sodium inj (thiopental sodium 0.53g) 5-6mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with 50% oxygen-air-4~7% desflurane inhalation and intravenous remifentanil continous infusion (effect site concentration 3-6ng/mL) during operation. Desflurane concentration is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.

Other names: Suprane soln. 240ml/Bottle

Propofol

Drug

On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with fresofol MCT 1% inj (1% propofol) 1.5-2.5mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with intravenous fresofol MCT 2% inj (2% propofol, effect site concentration 2.5-5μg/mL) and remifentanil (effect site concentration 3-6ng/mL) continous infusion. Effect site concentration of propofol is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.

Other names: Fresofol medium-chain triglyceride (MCT) 2% inj. 50mL

Primary outcomes

  1. changes in intraocular pressure (IOP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

    Time frame: 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

    T1 (baseline: initial IOP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)

Secondary outcomes

  1. changes in mean arterial pressure (MAP) in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

    Time frame: 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

    T1 (baseline: initial MAP before anesthesia induction), T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 minutes after position change to head down and right tilt), T5 (10 minutes after position change to head up and right tilt), T6 (30 minutes after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)

  2. changes in end tidal carbon dioxide in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

    Time frame: 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

    T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)

  3. changes in peak airway pressure in different positions during laparoscopic colorectal surgery under desflurane or propofol anesthesia.

    Time frame: 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

    T2 (immediately after endotracheal intubation), T3(after pneumoperitoneum in supine position), T4 (30 mins after position change to head down and right tilt), T5 (10 mins after position change to head up and right tilt), T6 (30 mins after position change to head down and right tilt) and T7 (5 minutes before endotracheal extubation)

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

Intraocular Pressure Changes During Laparoscopic Colorectal Surgery: Propofol Versus Desflurane Anesthesia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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