Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

Recruiting

• Conditions: Brain Tumor; Post-Op Complication; Anesthesia
• Interventions: Other: Quality of Recovery-15; Other: Glasgow Result Scale; Other: Risk Factors

• Registration Number: NCT04585633
• Lead Sponsor: Trakya University

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.

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-14
• Study Start: 2022-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Risk	Glasgow Result Scale	no complication develop within 30 days after the operation and high GOS value
High Risk	Risk Factors	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
Low Risk	Quality of Recovery-15	no complication develop within 30 days after the operation and high GOS value
Low Risk	Risk Factors	no complication develop within 30 days after the operation and high GOS value
High Risk	Quality of Recovery-15	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
High Risk	Glasgow Result Scale	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Centrum, Turkey