ONSD According to the Position During Laparoscopy

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Brief Title

ONSD According to the Position During Laparoscopy

Official Title

Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

ONSD and PaCO2

Secondary Outcome

 ONSD and PaCO2

Condition

Cholecystitis

Intervention

Desflurane

Study Arms / Comparison Groups

 Group 1
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

September 2013

Completion Date

September 2014

Primary Completion Date

September 2014

Eligibility Criteria

        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
      

Gender

Female

Ages

19 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Ki Tae Jung, M.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01937104

Organization ID

ONSD-P


Responsible Party

Principal Investigator

Study Sponsor

Chosun University Hospital


Study Sponsor

Ki Tae Jung, M.D., Study Chair, Department of Anesthesiology and Pain medicine School of Medicine, Chosun University


Verification Date

October 2014