Trials / Completed
CompletedNCT03910556
Re-craniotomy and Complications After Elective Neurosurgery
Predictive Factors of Re-craniotomy and Major Non-neurological Complications in Elective Neurosurgery: A Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 439 (actual)
- Sponsor
- Chiang Mai University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.
Detailed description
Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation. Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation. Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Propofol | intraoperative factors |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-02-01
- Completion
- 2019-02-01
- First posted
- 2019-04-10
- Last updated
- 2019-04-12
Source: ClinicalTrials.gov record NCT03910556. Inclusion in this directory is not an endorsement.