ONSD According to the Position During Laparoscopy

NCT01937104 | Completed DMC

• 1 other identifier: ONSD-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis; Ovarian Cyst; Ovarian Cancer; Uterine Myoma; Cervical Cancer

Keywords

Intracranial pressure; Laparoscopy; Optic nerve sheath diameter; Position

Outcome Measures

Primary Outcomes (1)

• ONSD and PaCO2

  ONSD and PaCO2 - 5 minutes after introducing positional change

  5 minutes after introducing positional change

Secondary Outcomes (1)

• ONSD and PaCO2

  5 minutes after introducing pneumoperitoneum

Other Outcomes (5)

• Preinduction ONSD

  prior to the induction of anesthesia, an expected average of 5 minutes

• ONSD and PaCO2

  5 minutes after induction of anesthesia

• ONSD and PaCO2

  15 minutes after positional change

Study Arms (2)

Group 1

EXPERIMENTAL

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; Drug: Remifentanil; Device: Ultrasonographic measurement of ONSD; Procedure: Mechanical ventilation; Procedure: Trendelenburg position - 30 degree

Group 2

EXPERIMENTAL

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

Interventions

Desflurane DRUG

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

Group 1; Group 2

Remifentanil DRUG

Adjuvant continuous administration \- adjust effect site concentration to maintain changes of vital sign below 20%

Also known as: Ultiva

Group 1; Group 2

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.

Group 1; Group 2

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.

Group 1; Group 2

Trendelenburg position - 30 degree PROCEDURE

Trendelenburg position - 30 degree

Group 1

Reverse Trendelenburg position - 30 degree PROCEDURE

Reverse Trendelenburg position - 30 degree

Group 2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chosun University Hospital: lead

Study Sites (1)

Chosun University Hospital

Gwangju, Donggu, 501-717, South Korea

Location

Related Publications (5)

• 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.

  PMID: 16517337 RESULT

• 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.

  PMID: 21463263 RESULT

• 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.

  PMID: 18786243 RESULT

• 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.

  PMID: 19636971 RESULT

• 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.

  PMID: 17668184 RESULT

MeSH Terms

Conditions

Cholecystitis; Ovarian Cysts; Ovarian Neoplasms; Myofibroma; Uterine Cervical Neoplasms

Interventions

Desflurane; Remifentanil; Respiration, Artificial

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Ki Tae Jung, M.D.

  Department of Anesthesiology and Pain medicine School of Medicine, Chosun University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist professor

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

KR (1)