Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

NCT03701529 | Completed

• 1 other identifier: 2018-09-004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterus Myoma; Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• difference of optic nerve sheath diameter

  optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)

  During the operation.

Study Arms (2)

Sevoflurane

EXPERIMENTAL

1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia.

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system.

Drug: Propofol

Interventions

Sevoflurane DRUG

1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.

Also known as: sevoflurane anesthesia

Sevoflurane

Propofol DRUG

2-5 mcg/ml of propofol is used for maintenance of anesthesia.

Also known as: propofol anesthesia

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam Sungshim Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Myofibroma; Uterine Neoplasms

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Choi Eun-Mi, Professor

  Kangnam Sungshim Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 15, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)