Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

NCT ID: NCT03701529

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-09-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Uterus Myoma Uterine Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Sevoflurane

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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sevoflurane anesthesia propofol anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Choi Eun-Mi, Professor

Role: STUDY_CHAIR

Kangnam Sungshim Hospital

Locations

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Kangnam Sungshim Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-09-004

Identifier Type: -

Identifier Source: org_study_id

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