IOP Changes With Different Anesthetic Agents During Laparoscopic Colorectal Surgery

NCT03016234 | Completed

• 1 other identifier: VC16OISI0143
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Keywords

intraocular pressure; trendelenburg position; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

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

  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)

  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 (3)

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

  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

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

  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

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

  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

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

inhalation anesthesia administration for maintenance of anesthesia

Drug: Desflurane

Propofol

ACTIVE COMPARATOR

intravenous anesthesia administration for maintenance of anesthesia

Drug: Propofol

Interventions

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.

Also known as: Suprane soln. 240ml/Bottle

Desflurane

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.

Also known as: Fresofol medium-chain triglyceride (MCT) 2% inj. 50mL

Propofol

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

Saint Vincent's Hospital, Korea

Suwon, Gyonggido, 16247, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27247511 RESULT

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Desflurane; Propofol

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Kwon hui Seo, MD

  Saint Vincent's Hospital, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of anesthesia and pain medicine, Saint Vincent's Hospital, Korea

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 10, 2017
• Study Start: September 29, 2016
• Primary Completion: March 8, 2017
• Study Completion: March 8, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)