ONSD According to the Position During Laparoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Chosun University Hospital
Sponsor:
Information provided by (Responsible Party):
Ki Tae Jung, Chosun University Hospital
ClinicalTrials.gov Identifier:
NCT01937104
First received: September 4, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Cholecystitis
Ovarian Cyst
Ovarian Cancer
Uterine Myoma
Cervical Cancer
Drug: Desflurane
Drug: Remifentanil
Device: Ultrasonographic measurement of ONSD
Procedure: Mechanical ventilation
Procedure: Trendelenburg position - 30 degree
Procedure: Reverse Trendelenburg position - 30 degree

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Optic Nerve Sheath Diameter According to Position During Laparoscopy

Resource links provided by NLM:


Further study details as provided by Chosun University Hospital:

Primary Outcome Measures:
  • ONSD and PaCO2 [ Time Frame: 5 minutes after introducing positional change ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 5 minutes after introducing positional change


Secondary Outcome Measures:
  • ONSD and PaCO2 [ Time Frame: 5 minutes after introducing pneumoperitoneum ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum


Other Outcome Measures:
  • Preinduction ONSD [ Time Frame: prior to the induction of anesthesia, an expected average of 5 minutes ] [ Designated as safety issue: No ]
    ONSD - preinduction (prior to the induction of anesthesia in the operating room)

  • ONSD and PaCO2 [ Time Frame: 5 minutes after induction of anesthesia ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 5 minutes after induction of anesthesia

  • ONSD and PaCO2 [ Time Frame: 15 minutes after positional change ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 15 min after positional change

  • ONSD and PaCO2 [ Time Frame: 30 minutes after positional change ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 30 minutes after positional change

  • ONSD and PaCO2 [ Time Frame: 5 minutes after discontinuing pneumoperitoneum ] [ Designated as safety issue: No ]
    ONSD and PaCO2 - 5 minutes after discontinuing pneumoperitoneum


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Other Name: Desflurane
Drug: Remifentanil

Adjuvant continuous administration

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

Other Name: 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

Other Name: Desflurane
Drug: Remifentanil

Adjuvant continuous administration

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

Other Name: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937104

Contacts
Contact: Ki Tae Jung, M.D. +82-62-220-3223 mdmole@chosun.ac.kr
Contact: Hyun Young Lee, M.D. +82-62-220-3223 lsopp@naver.com

Locations
Korea, Republic of
Chosun University Hospital Recruiting
Gwangju, Donggu, Korea, Republic of, 501-717
Contact: Ki Tae Jung, M.D.    +82-62-220-3223    mdmole@chosun.ac.kr   
Contact: Hyun Young Lee, M.D.    +82-62-220-3223    lsopp@naver.com   
Principal Investigator: Ki Tae Jung, M.D.         
Principal Investigator: Huyn Young Lee, M.D.         
Sponsors and Collaborators
Chosun University Hospital
Investigators
Study Chair: Ki Tae Jung, M.D. Department of Anesthesiology and Pain medicine School of Medicine, Chosun University
  More Information

Publications:
Responsible Party: Ki Tae Jung, Assist professor, Chosun University Hospital
ClinicalTrials.gov Identifier: NCT01937104     History of Changes
Other Study ID Numbers: ONSD-P
Study First Received: September 4, 2013
Last Updated: March 18, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Chosun University Hospital:
Intracranial pressure
Laparoscopy
Optic nerve sheath diameter
Position

Additional relevant MeSH terms:
Uterine Cervical Diseases
Uterine Cervical Neoplasms
Cholecystitis
Acalculous Cholecystitis
Myoma
Ovarian Neoplasms
Ovarian Cysts
Leiomyoma
Myofibroma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Cysts
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 23, 2014