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ONSD According to the Position During Laparoscopy (ONSD)

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ClinicalTrials.gov Identifier: NCT01937104
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Ki Tae Jung, Chosun University Hospital

September 4, 2013
September 9, 2013
October 30, 2014
September 2013
September 2014   (Final data collection date for primary outcome measure)
ONSD and PaCO2 [ Time Frame: 5 minutes after introducing positional change ]
ONSD and PaCO2 - 5 minutes after introducing positional change
Same as current
Complete list of historical versions of study NCT01937104 on ClinicalTrials.gov Archive Site
ONSD and PaCO2 [ Time Frame: 5 minutes after introducing pneumoperitoneum ]
ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum
Same as current
  • Preinduction ONSD [ Time Frame: prior to the induction of anesthesia, an expected average of 5 minutes ]
    ONSD - preinduction (prior to the induction of anesthesia in the operating room)
  • ONSD and PaCO2 [ Time Frame: 5 minutes after induction of anesthesia ]
    ONSD and PaCO2 - 5 minutes after induction of anesthesia
  • ONSD and PaCO2 [ Time Frame: 15 minutes after positional change ]
    ONSD and PaCO2 - 15 min after positional change
  • ONSD and PaCO2 [ Time Frame: 30 minutes after positional change ]
    ONSD and PaCO2 - 30 minutes after positional change
  • ONSD and PaCO2 [ Time Frame: 5 minutes after discontinuing pneumoperitoneum ]
    ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum
Same as current
 
ONSD According to the Position During Laparoscopy
Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy
Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.
  1. Purpose There can be many physiologic changes during laparoscopic surgery. Increase of intracerebral pressure (ICP) is one of them, which has known to be associated with arterial concentration of carbon dioxide or positional changes. Changes of ICP can be measured directly by invasive method. However, optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.
  2. Hypothesis Changes of ONSD will be shown according to the positional change during laparoscopic surgery, and these can reflect the changes of ICP.
  3. Objectives Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years, are allocated into 2 groups.

    • Group 1: Laparoscopic gynecological surgery, (Trendelenburg position)
    • Group 2: Laparoscopic cholecystectomy, (Reverse trendelenburg position)
  4. Methods Patients are premedicated with midazolam 0.5 mg/kg before transported to the operating room. Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).

    Anesthesia are induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Anesthesia is maintained with desflurane in addition to the continuous infusion of remifentanil. Radial arterial cannulation is done for invasive arterial blood pressure monitoring.

    After induction of anesthesia, when stabilization of cardiovascular status is achieved, optic nerve sheath diameter (ONSD) is measured by ultrasonographic measurement. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.

    ONSD was measured at 7 serial time points during surgery:

    1. Preinduction (prior to the induction of anesthesia in the operating room)
    2. 5 minutes after induction of anesthesia
    3. 5 minutes after introducing pneumoperitoneum
    4. 5 minutes after positional change
    5. 15 minutes after positional change
    6. 30 minutes after positional change
    7. 5 minutes after discontinuing pneumoperitoneum Arterial blood gas analysis is performed to evaluate the arterial carbon dioxide concentration (PaCO2) level at each time point.
  5. Statistical Analysis All data are expressed as numbers (%) or mean ± standard deviation. Repeated measures ANOVA will be performed to compare the parameters at specific time points during surgery.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Cholecystitis
  • Ovarian Cyst
  • Ovarian Cancer
  • Uterine Myoma
  • Cervical Cancer
  • Drug: Desflurane

    Anesthesia with desflurane in both Group 1 and Group 2

    - adjust MAC to maintain BIS between 40-60

  • Drug: Remifentanil

    Adjuvant continuous administration

    - adjust effect site concentration to maintain changes of vital sign below 20%

    Other Name: Ultiva
  • Device: Ultrasonographic measurement of ONSD
    Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.
  • Procedure: Mechanical ventilation
    After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.
  • Procedure: Trendelenburg position - 30 degree
    Trendelenburg position - 30 degree
  • Procedure: Reverse Trendelenburg position - 30 degree
    Reverse Trendelenburg position - 30 degree
  • Experimental: Group 1

    Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60

    Drug: Remifentanil Adjuvant continuous administration

    - adjust effect site concentration to maintain changes of vital sign below 20%

    Device: Ultrasonographic measurement of ONSD

    Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.

    Trendelenburg position - 30 degree

    Interventions:
    • Drug: Desflurane
    • Drug: Remifentanil
    • Device: Ultrasonographic measurement of ONSD
    • Procedure: Mechanical ventilation
    • Procedure: Trendelenburg position - 30 degree
  • Experimental: Group 2

    Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60

    Drug: Remifentanil Adjuvant continuous administration

    - adjust effect site concentration to maintain changes of vital sign below 20%

    Device: Ultrasonographic measurement of ONSD

    Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.

    Reverse Trendelenburg position - 30 degree

    Interventions:
    • Drug: Desflurane
    • Drug: Remifentanil
    • Device: Ultrasonographic measurement of ONSD
    • Procedure: Mechanical ventilation
    • Procedure: Reverse Trendelenburg position - 30 degree

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years

Exclusion Criteria:

  • Aged unger 18 years or over 65 years
  • American society of anesthesiologist class (ASA) III-IV
  • Patients with increased intracranial pressure (e.g. hydrocephalus, intracranial hemorrhage, etc.)
  • Patients with opthalmologic disease
Sexes Eligible for Study: Female
19 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01937104
ONSD-P
Yes
Not Provided
Not Provided
Ki Tae Jung, Chosun University Hospital
Chosun University Hospital
Not Provided
Study Chair: Ki Tae Jung, M.D. Department of Anesthesiology and Pain medicine School of Medicine, Chosun University
Chosun University Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP