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Trial record 21 of 577 for:    CARBON DIOXIDE AND anesthesia

IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT03016234
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Seo, Kwon Hui, Saint Vincent's Hospital, Korea

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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: Desflurane Drug: Propofol Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Intraocular Pressure Changes During Laparoscopic Colorectal Surgery: Propofol Versus Desflurane Anesthesia
Actual Study Start Date : September 29, 2016
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Desflurane
inhalation anesthesia administration for maintenance of anesthesia
Drug: Desflurane
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 Name: Suprane soln. 240ml/Bottle

Active Comparator: Propofol
intravenous anesthesia administration for maintenance of anesthesia
Drug: Propofol
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 Name: Fresofol medium-chain triglyceride (MCT) 2% inj. 50mL




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016234


Locations
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Korea, Republic of
Saint Vincent's Hospital, Korea
Suwon, Gyonggido, Korea, Republic of, 16247
Sponsors and Collaborators
Saint Vincent's Hospital, Korea
Investigators
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Principal Investigator: Kwon hui Seo, MD Saint Vincent's Hospital, Korea

Publications of Results:
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Responsible Party: Seo, Kwon Hui, Clinical Assistant Professor, Department of anesthesia and pain medicine, Saint Vincent's Hospital, Korea, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT03016234     History of Changes
Other Study ID Numbers: VC16OISI0143
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seo, Kwon Hui, Saint Vincent's Hospital, Korea:
intraocular pressure
trendelenburg position
pneumoperitoneum
Additional relevant MeSH terms:
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Anesthetics
Propofol
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation