Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

September 2, 2020 updated by: Hallym University Kangnam Sacred Heart Hospital

Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • propofol anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)
During the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Kangnam Sacred Heart Hospital

Investigators

  • Study Chair: Choi Eun-Mi, Professor, Kangnam Sungshim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

September 16, 2019

Study Completion (Actual)

September 16, 2019

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 8, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-09-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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