ONSD According to the Position During Laparoscopy (ONSD)

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Ovarian Cancer; Cholecystitis; Uterine Myoma; Ovarian Cyst
• Intervention / Treatment: Drug: Desflurane; Drug: Remifentanil; Device: Ultrasonographic measurement of ONSD; Procedure: Mechanical ventilation; Procedure: Trendelenburg position - 30 degree; Procedure: Reverse Trendelenburg position - 30 degree

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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Donggu
    • Gwangju, Donggu, Korea, Republic of, 501-717
      • Chosun university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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 Names: 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
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	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 Names: 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: Reverse Trendelenburg position - 30 degree; Reverse Trendelenburg position - 30 degree

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ONSD and PaCO2	ONSD and PaCO2 - 5 minutes after introducing positional change	5 minutes after introducing positional change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ONSD and PaCO2	ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum	5 minutes after introducing pneumoperitoneum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preinduction ONSD	ONSD - preinduction (prior to the induction of anesthesia in the operating room)	prior to the induction of anesthesia, an expected average of 5 minutes
ONSD and PaCO2	ONSD and PaCO2 - 5 minutes after induction of anesthesia	5 minutes after induction of anesthesia
ONSD and PaCO2	ONSD and PaCO2 - 15 min after positional change	15 minutes after positional change
ONSD and PaCO2	ONSD and PaCO2 - 30 minutes after positional change	30 minutes after positional change
ONSD and PaCO2	ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum	5 minutes after discontinuing pneumoperitoneum

Collaborators and Investigators

• Sponsor: Chosun University Hospital
• Investigators: Study Chair: Ki Tae Jung, M.D., Department of Anesthesiology and Pain medicine School of Medicine, Chosun University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 6, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Laparoscopy; Optic nerve sheath diameter; Position; Intracranial pressure
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Connective Tissue Diseases; Gallbladder Diseases; Biliary Tract Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Cholecystitis; Leiomyoma; Myofibroma; Ovarian Cysts; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Inhalation; Remifentanil; Desflurane
• Other Study ID Numbers: ONSD-P