Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

Sponsor
Trakya University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04585633
Collaborator
(none)
100
1
18
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of Recovery-15
  • Other: Glasgow Result Scale
  • Other: Risk Factors

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Low Risk

no complication develop within 30 days after the operation and high GOS value

Other: Quality of Recovery-15
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.
Other Names:
  • QoR-15
  • Other: Glasgow Result Scale
    Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
    Other Names:
  • GOS
  • Other: Risk Factors
    Pre-operative: 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 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 Post-operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications, hemodynamic data, blood gas data

    High Risk

    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

    Other: Quality of Recovery-15
    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.
    Other Names:
  • QoR-15
  • Other: Glasgow Result Scale
    Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
    Other Names:
  • GOS
  • Other: Risk Factors
    Pre-operative: 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 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 Post-operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications, hemodynamic data, blood gas data

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Recovery-15 [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 Outcome Measures

    1. Complication [during the hospital stay]

      the development of complication or complications during hospitalization 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

    2. Glasgow Outcome Scale [30th day after the operation (1 time)]

      Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trakya University Edirne Centrum Turkey 22030

    Sponsors and Collaborators

    • Trakya University

    Investigators

    • Principal Investigator: SEVTAP HEKİMOĞLU ŞAHİN, Professor, Trakya University
    • Principal Investigator: ONUR KÜÇÜK, Resident, Trakya University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Onur Kucuk, Department of anesthesiology and reanimation Resident Doctor, Trakya University
    ClinicalTrials.gov Identifier:
    NCT04585633
    Other Study ID Numbers:
    • TÜTF-BAEK 2020/136
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Onur Kucuk, Department of anesthesiology and reanimation Resident Doctor, Trakya University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2021