Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor; Anesthesia; Post-Op Complication
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: ONUR KÜÇÜK, Resident; Phone Number: +9 05358543333; Email: dr.okucuk@gmail.com

Study Locations

• Turkey
  • Centrum
    • Edirne, Centrum, Turkey, 22030
      • Recruiting
      • Trakya University
      • Contact: ONUR KÜÇÜK, Resident; Phone Number: +905358543333; Email: dr.okucuk@gmail.com
      • Contact: SEVTAP HEKİMOĞLU ŞAHİN, Professor; Email: sevtaphekimoglu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	score change before surgery and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	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	during the hospital stay
Glasgow Outcome 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. 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.	30th day after the operation (1 time)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Recovery; craniotomy; post-operative; risk prediction score; anesthesia recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: TÜTF-BAEK 2020/136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No