Effect of Anesthetic Agents on Optic Nerve Sheath Diameter

Uterine Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701529
• Other study ID #: 2018-09-004
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: January 2020
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Uterine Cancer
• Uterine Neoplasms
• Uterus Myoma

Intervention

Drug:
• Sevoflurane
1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
• Propofol
2-5 mcg/ml of propofol is used for maintenance of anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Kangnam Sungshim Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.