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Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

T

Trakya University

Status

Enrolling

Conditions

Post-Op Complication
Brain Tumor
Anesthesia

Treatments

Other: Risk Factors
Other: Quality of Recovery-15
Other: Glasgow Result Scale

Study type

Observational

Funder types

Other

Identifiers

NCT04585633
TÜTF-BAEK 2020/136

Details and patient eligibility

About

The aim of our study is to prevent unnecessary intensive care unit hospitalizations by developing a scoring system to detect low-risk patients after elective intracranial neurosurgery operation.

Full description

In this study, the data of patients who are planned to undergo craniotomy by neurosurgery will be collected as a file scan (medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values). The pre-operative Quality of Recovery-15 (QoR-15) score will be recorded before the patient is taken into operation. Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples will be written from the anesthesia document after the operation is over. For the study, the application of the anesthesiologist for the patient will not be interfered. After the operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications (moderate to severe intracerebral hemorrhage on brain CT, intracranial hypertension requiring post op surgical drainage, development of status epilepticus or seizures, the need for tracheal intubation and mechanical ventilation after surgery, decrease in GKS, unmanageable agitation that requires restriction or sedation, need for respiratory failure and oxygen therapy, serious motor deficit and exitus) will be recorded in the service where the patient is sent. The post-operative QoR-15 score will be calculated 24 hours after the operation. Pre-operative and post-operative calculated scores of the patient will be evaluated and anesthesia recovery score will be created. With this recovery score, post-operative mortality and morbidity estimates will be made. The length of hospital stay of the patient will be recorded. Glasgow Result Scale (GOS) score will be determined 30 days after the patient operation. In this way, 1 month morbidity and mortality of the patient will be evaluated. The collected results will be statistically associated with anesthesia recovery and operation complications.

As a result, in our study; post-operative risk prediction score will be created in patients undergoing intracranial surgery with elective craniotomy.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. To undergo intracranial operation with elective craniotomy
  2. No history of congestive heart failure
  3. No kidney and liver dysfunction
  4. Not pregnant
  5. To be over 18 years old

Exclusion criteria

  1. To undergo an intracranial operation with emergency craniotomy
  2. Patients with a history of congestive heart failure
  3. Patients with kidney and liver dysfunction
  4. Pregnant patients
  5. Patients under 18 years old

Trial design

100 participants in 2 patient groups

Low Risk
Description:
no complication develop within 30 days after the operation and high GOS value
Treatment:
Other: Risk Factors
Other: Glasgow Result Scale
Other: Quality of Recovery-15
High Risk
Description:
complication or complications develop within 30 days after the operation and low GOS value Complications: * Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm), * İntracranial hypertension requiring post op surgical drainage, * Status epilepticus or seizures, * The need for tracheal intubation or use of mechanical ventilation after surgery, * Decrease in GKS, * Unmanageable agitation that requires restriction or sedation, * Need for respiratory failure and oxygen therapy, * Unexpected serious motor deficit * Died
Treatment:
Other: Risk Factors
Other: Glasgow Result Scale
Other: Quality of Recovery-15

Trial contacts and locations

1

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Central trial contact

ONUR KÜÇÜK, Resident

Data sourced from clinicaltrials.gov

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