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NCT Number: NCT01937104

ONSD According to the 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.

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Key information

About this study

  • 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.
  • Hypothesis Changes of ONSD will be shown according to the positional change during laparoscopic surgery, and these can reflect the changes of ICP.
  • 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)
  • 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:

  • Preinduction (prior to the induction of anesthesia in the operating room)
  • 5 minutes after induction of anesthesia
  • 5 minutes after introducing pneumoperitoneum
  • 5 minutes after positional change
  • 15 minutes after positional change
  • 30 minutes after positional change
  • 5 minutes after discontinuing pneumoperitoneum Arterial blood gas analysis is performed to evaluate the arterial carbon dioxide concentration (PaCO2) level at each time point.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Desflurane

Drug

Anesthesia with desflurane in both Group 1 and Group 2

  • adjust MAC to maintain BIS between 40-60

Remifentanil

Drug

Adjuvant continuous administration

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

Other names: Ultiva

Ultrasonographic measurement of ONSD

Device

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.

mechanical ventilation

Procedure

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.

Trendelenburg position - 30 degree

Procedure

Trendelenburg position - 30 degree

Reverse Trendelenburg position - 30 degree

Procedure

Reverse Trendelenburg position - 30 degree

Primary outcomes

  1. ONSD and PaCO2

    Time frame: 5 minutes after introducing positional change

    ONSD and PaCO2 - 5 minutes after introducing positional change

Secondary outcomes

  1. ONSD and PaCO2

    Time frame: 5 minutes after introducing pneumoperitoneum

    ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum

Other outcomes

  1. 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)

  2. ONSD and PaCO2

    Time frame: 5 minutes after induction of anesthesia

    ONSD and PaCO2 - 5 minutes after induction of anesthesia

  3. ONSD and PaCO2

    Time frame: 15 minutes after positional change

    ONSD and PaCO2 - 15 min after positional change

  4. ONSD and PaCO2

    Time frame: 30 minutes after positional change

    ONSD and PaCO2 - 30 minutes after positional change

  5. ONSD and PaCO2

    Time frame: 5 minutes after discontinuing pneumoperitoneum

    ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum

Sponsors and collaborators

Lead sponsor

Chosun University Hospital

Other

Registry information

Official study title

Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy

Acronym: ONSD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Oct 30, 2014

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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