Postoperative Risk Prediction Score After Elective Intracranial Neurosurgery Operation

NCT04585633 | Unknown DMC

• 1 other identifier: TÜTF-BAEK 2020/136
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor; Post-Op Complication; Anesthesia

Keywords

craniotomy; Quality of Recovery; post-operative; risk prediction score; anesthesia recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complication

  during the hospital stay

• Glasgow Outcome Scale

  30th day after the operation (1 time)

Study Arms (2)

Low Risk

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

Other: Quality of Recovery-15; Other: Glasgow Result Scale; Other: Risk Factors

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; Other: Glasgow Result Scale; Other: Risk Factors

Interventions

Quality of Recovery-15 OTHER

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.

Also known as: QoR-15

High Risk; Low Risk

Glasgow Result Scale OTHER

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.

Also known as: GOS

High Risk; Low Risk

Risk Factors OTHER

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; Low Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Postoperative Complications

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• SEVTAP HEKİMOĞLU ŞAHİN, Professor

  Trakya University

  PRINCIPAL INVESTIGATOR

• ONUR KÜÇÜK, Resident

  Trakya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ONUR KÜÇÜK, Resident

CONTACT

05358543333; dr.okucuk@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation Resident Doctor

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: October 14, 2020
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)