Clinical trial NCT04585633: Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation
Official title: Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor
Post-Op Complication
Anesthesia
Keywords: craniotomy
Quality of Recovery
post-operative
risk prediction score
anesthesia recovery
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned to include intracranial operations performed by craniotomy in a 2-year period by Trakya University Faculty of Medicine, Department of Neurosurgery.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Recovery-15
timeFrame: score change before surgery and 24 hours after surgery
Secondary outcomes:
measure: Complication
timeFrame: during the hospital stay
measure: Glasgow Outcome Scale
timeFrame: 30th day after the operation (1 time)
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centrum
Study officials:
affiliation: Trakya University
name: SEVTAP HEKİMOĞLU ŞAHİN, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: ONUR KÜÇÜK, Resident
role: PRINCIPAL_INVESTIGATOR
References: