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Clinical Trials/NCT04585633
NCT04585633
Recruiting
Not Applicable

Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

Trakya University1 site in 1 country100 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumor
Sponsor
Trakya University
Enrollment
100
Locations
1
Primary Endpoint
Quality of Recovery-15
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Onur Kucuk

Department of anesthesiology and reanimation Resident Doctor

Trakya University

Eligibility Criteria

Inclusion Criteria

  • To undergo intracranial operation with elective craniotomy
  • No history of congestive heart failure
  • No kidney and liver dysfunction
  • Not pregnant
  • To be over 18 years old

Exclusion Criteria

  • To undergo an intracranial operation with emergency craniotomy
  • Patients with a history of congestive heart failure
  • Patients with kidney and liver dysfunction
  • Pregnant patients
  • Patients under 18 years old

Outcomes

Primary Outcomes

Quality of Recovery-15

Time Frame: score change before surgery and 24 hours after surgery

Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150.

Secondary Outcomes

  • Glasgow Outcome Scale(30th day after the operation (1 time))
  • Complication(during the hospital stay)

Study Sites (1)

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