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Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

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ClinicalTrials.gov Identifier: NCT03701529
Recruitment Status : Not yet recruiting
First Posted : October 10, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hallym University Kangnam Sacred Heart Hospital

Brief Summary:
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.

Condition or disease Intervention/treatment Phase
Uterus Myoma Uterine Cancer Drug: Sevoflurane Drug: Propofol Not Applicable

Detailed Description:

Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.

Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sevoflurane
1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia.
Drug: Sevoflurane
1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
Other Name: sevoflurane anesthesia

Active Comparator: Propofol
2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system.
Drug: Propofol
2-5 mcg/ml of propofol is used for maintenance of anesthesia.
Other Name: propofol anesthesia




Primary Outcome Measures :
  1. difference of optic nerve sheath diameter [ Time Frame: During the operation. ]
    optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 30 minutes after pneumoperitoneum and trendelenburg position / 60 minutes after pneumoperitoneum and trendelenburg position / skin closure)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy

Exclusion Criteria:

  • history of brain hemorrhage or brain infarction
  • liver disease or end stage renal disease
  • glaucoma or any signs of increased intraocular pressure
  • combined wtih other types of operation
  • patient refusal
  • weight less than 40 kg or over 100 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701529


Contacts
Contact: Jun In-Jung, fellow 82-10-9312-0162 christine17@hanmail.net

Locations
Korea, Republic of
Kangnam Sungshim Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jun , Fellow         
Sponsors and Collaborators
Hallym University Kangnam Sacred Heart Hospital
Investigators
Study Chair: Choi Eun-Mi, Professor Kangnam Sungshim Hospital

Responsible Party: Hallym University Kangnam Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03701529     History of Changes
Other Study ID Numbers: 2018-09-004
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation