Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01489137
Other study ID # JHBahk_fixation_remifentanil
Secondary ID
Status Completed
Phase N/A
First received December 5, 2011
Last updated August 15, 2012
Start date November 2011

Study information

Verified date August 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- patients undergoing neurosurgery that require head fixation with mayfield head holder

- patients who agree to our study

Exclusion Criteria:

- patients who don't agree to our study

- BMI<16.0 or BMI>30

- cardiovascular disease, pulmonary disease, renal disease

- alcoholic abuser or drug abuser

- patients who takes any drug having an influence on cardiovascular system or sympathetic nervous system

- any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction to peri-fixation period

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
remifentanil
According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during head fixation. And, For this allocation of dose of remifentanil the investigators use biased coin design up-and-down method. For the first patient, the dose of remifentanil would be fixed at 5.5ng/ml which we predict as EC90. And, step size of dose is 0.5ng/ml.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean arterial blood pressure mean arterial blood pressure will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation. peri-fixation periord No
Primary heart rate heart rate will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation. peri-fixation periord No
See also
  Status Clinical Trial Phase
Recruiting NCT05023434 - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT03286335 - Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT03276676 - [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors Phase 2
Completed NCT02851355 - Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
Completed NCT02713087 - Vasopressor Effects in Anesthetized Patients Phase 4
Completed NCT02558569 - The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block Phase 4
Completed NCT02409121 - A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers N/A
Terminated NCT02674945 - Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
Withdrawn NCT02165995 - Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery N/A
Completed NCT01171469 - Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor Phase 1
Withdrawn NCT01202539 - Real-time Assessment of Frameless Intrafraction Motion
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2
Completed NCT00760409 - Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI N/A
Completed NCT00503204 - Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour Phase 1