Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2013-09-30
2014-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
Desflurane
Anesthesia with desflurane in both Group 1 and Group 2
\- adjust MAC to maintain BIS between 40-60
Remifentanil
Adjuvant continuous administration
\- adjust effect site concentration to maintain changes of vital sign below 20%
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.
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.
Trendelenburg position - 30 degree
Trendelenburg position - 30 degree
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
Desflurane
Anesthesia with desflurane in both Group 1 and Group 2
\- adjust MAC to maintain BIS between 40-60
Remifentanil
Adjuvant continuous administration
\- adjust effect site concentration to maintain changes of vital sign below 20%
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.
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.
Reverse Trendelenburg position - 30 degree
Reverse Trendelenburg position - 30 degree
Interventions
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Desflurane
Anesthesia with desflurane in both Group 1 and Group 2
\- adjust MAC to maintain BIS between 40-60
Remifentanil
Adjuvant continuous administration
\- adjust effect site concentration to maintain changes of vital sign below 20%
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.
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.
Trendelenburg position - 30 degree
Trendelenburg position - 30 degree
Reverse Trendelenburg position - 30 degree
Reverse Trendelenburg position - 30 degree
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* American society of anesthesiologist class (ASA) III-IV
* Patients with increased intracranial pressure (e.g. hydrocephalus, intracranial hemorrhage, etc.)
* Patients with opthalmologic disease
19 Years
65 Years
FEMALE
No
Sponsors
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Chosun University Hospital
OTHER
Responsible Party
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Ki Tae Jung
Assist professor
Principal Investigators
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Ki Tae Jung, M.D.
Role: STUDY_CHAIR
Department of Anesthesiology and Pain medicine School of Medicine, Chosun University
Locations
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Chosun University Hospital
Gwangju, Donggu, South Korea
Countries
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References
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Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.
Moretti R, Pizzi B. Ultrasonography of the optic nerve in neurocritically ill patients. Acta Anaesthesiol Scand. 2011 Jul;55(6):644-52. doi: 10.1111/j.1399-6576.2011.02432.x. Epub 2011 Apr 4.
Geeraerts T, Newcombe VF, Coles JP, Abate MG, Perkes IE, Hutchinson PJ, Outtrim JG, Chatfield DA, Menon DK. Use of T2-weighted magnetic resonance imaging of the optic nerve sheath to detect raised intracranial pressure. Crit Care. 2008;12(5):R114. doi: 10.1186/cc7006. Epub 2008 Sep 11.
Moretti R, Pizzi B, Cassini F, Vivaldi N. Reliability of optic nerve ultrasound for the evaluation of patients with spontaneous intracranial hemorrhage. Neurocrit Care. 2009 Dec;11(3):406-10. doi: 10.1007/s12028-009-9250-8.
Geeraerts T, Launey Y, Martin L, Pottecher J, Vigue B, Duranteau J, Benhamou D. Ultrasonography of the optic nerve sheath may be useful for detecting raised intracranial pressure after severe brain injury. Intensive Care Med. 2007 Oct;33(10):1704-11. doi: 10.1007/s00134-007-0797-6. Epub 2007 Aug 1.
Other Identifiers
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ONSD-P
Identifier Type: -
Identifier Source: org_study_id
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