Clinical Trials Logo
  1. Home
  2. Neurosurgery
  3. NCT02318199
  4. Details
NCT02318199 Clinical Trial

Emergence Agitation in Adult Patients After Intracranial Surgery

Neurosurgery Clinical Trial

Official title:
Emergence Agitation During Recovery From Intracranial Surgery Under General Anesthesia: a Prospective Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02318199
Other study ID # KY2014-034-01
Secondary ID
Status Completed
Phase N/A
First received December 11, 2014
Last updated August 4, 2015
Start date January 2015
Est. completion date August 2015

Study information
Verified date August 2015
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority China: Beijing Municipal Health Bureau
Study type Observational

Clinical Trial Summary

Emergence agitation is a frequent complication that can have serious consequences during recovery from general anesthesia. However, agitation has been poorly investigated in patients after craniotomy. In this prospective multicenter cohort study, adult patients will be enrolled after craniotomy and emergence agitation will be evaluated. The incidence, risk factors and outcome will be investigated.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Both supratentorial and infratentorial intradural cranial operations

Exclusion Criteria:

- Unarousable state (SAS=1) during the first 24 hours after the operation

- Interval longer than 24 hours between the end of the surgery and neurosurgical ICU admission

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Anesthesia recovery after intracranial surgery
Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.

Locations
Country Name City State
China Daxing Teaching Hospital, Capital Medical University Beijing Beijing
China Fujian Provincial Clinical College, Fujian Medical University Fuzhou Fujian
China Inner Mongolia People's Hospital Hohhot Inner Mongolia
China Bethune International Peace Hospital, Hebei Medical University Shijiazhuang Hebei

Sponsors (2)
Lead Sponsor Collaborator
Capital Medical University Beijing Municipal Administration of Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Emergence agitation Emergence agitation is measured by sedation-agitation scale (SAS) and is defined as SAS=5-7. 12 hours after operation No
See also
  Status Clinical Trial Phase
Completed NCT03682198 - Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions N/A
Withdrawn NCT00925093 - Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection Phase 1
Completed NCT05264012 - Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
Recruiting NCT05397574 - Intraoperative Hyperspectral Imaging for Fluorescence Guided Surgery in Low Grade Gliomas
Completed NCT04153396 - Preemptive Infiltration With Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy Phase 4
Recruiting NCT03087981 - Parameters Analysis in Neurosurgical Critical Patients Through Big Data Acquisition N/A
Completed NCT01513213 - Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient N/A
Recruiting NCT04034836 - Parecoxib as an Adjuvant to Scalp Nerve Blocks for Relief of Post-craniotomy Pain Phase 4
Completed NCT03532256 - Post-op Crowd Sourcing Health Data Via Text-messaging
Completed NCT05108337 - Superficial Cervical Plexus Block for Postoperative Chronic Pain N/A
Completed NCT02987816 - Neurosurgical Skill Enhancement Using Transcranial Stimulation N/A
Completed NCT03193905 - Preventing Inadvertent Hypothermia in Patients Undergoing Major Spinal Surgery N/A
Completed NCT00122096 - Perioperative Inflammation and Cyclooxygenase 2 (COX-2) Phase 4
Recruiting NCT05874050 - Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.
Completed NCT01122537 - Characterization and Differential Diagnosis of Postneurosurgical Meningitis N/A
Recruiting NCT05294185 - Intra-operative Hyperspectral Imaging in Neurosurgery
Completed NCT04142203 - Implementation of 23 Hour Surgery Model in a Tertiary Hospital
Completed NCT05169281 - Distribution of Medication Disposal Packets - Acute Opioid Prescribing N/A
Recruiting NCT06264037 - The Experience in Neurorehabilitation Setting: a Qualitative Study
Recruiting NCT05860790 - Prospective Validation of Clinical Prediction Model for Venous Thromboembolism Following Neurosurgery