A Greek-designed ERAS Protocol in Elective Craniotomy

Sponsor

University of Thessaly (Other)

Overall Status

Recruiting

CT.gov ID

NCT05962684

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital.

Condition or Disease	Intervention/Treatment	Phase
ERAS Craniotomy	Other: ERAS

Detailed Description

In this study, the investigators have integrated the most current data from literature aiming to investigate the effectiveness of a contemporary ERAS protocol for elective cranial neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such protocol will shorten the postoperative length of stay, minimize the complication rates, and improve the overall clinical status of patients undergoing elective craniotomy compared to the standard perioperative care

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Greek-designed Enhanced Recovery After Surgery (ERAS) Protocol in Elective Cranial Neurosurgical Procedures: An Observational Study

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
ERAS	Other: ERAS Implementation of ERAS protocol in elective craniotomy patients

Outcome Measures

Primary Outcome Measures

Hospital Length of Stay [up to 7 days]
The days the patient stays in hospital

Secondary Outcome Measures

Pain score [Postoperative Day 1 to discharge, an average of 7 days]
Pain intensity as measured by Visual Analogue Scale (VAS)
Mental status [1 day at discharge]
Mental status as measured by Glasgow Coma Scale (GCS) Minimum value : 3 Maximum value : 15 Higher scores mean a better outcome
Patient's satisfaction [1 day at discharge and 1 month postoperatively]
Patient's satisfaction as measured by a Likert Scale
Anxiety and Depression [Preoperatively, second postoperative day and one month postoperatively]
Anxiety and Depression level as measured by Hospital Anxiety and Depression Scale (HADS)
Personality Index [Preoperatively, second postoperative day and one month postoperatively]
Personality Index as measured by TIPI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Medically suitable for elective craniotomy
ASA-PS I-III

Exclusion Criteria:

traumatic lesions
pathology requiring emergent surgery
preoperative loss of consciousness
severe co-morbidities that may affect postoperative recovery (e.g. paralysis, autoimmune diseases, myocardial or severe infarction, heart, liver or lung malfunction, severe mental illness etc.)
recurrent tumor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Thessaly	Larissa		Greece	41110

Sponsors and Collaborators

University of Thessaly

Investigators

Study Director: Eleni Arnaoutolglou, MD, PhD, University of Thessaly
Study Chair: Konstantinos Fountas, MD, PhD, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena Arnaoutoglou, Professor in Anesthesiology, University of Thessaly

ClinicalTrials.gov Identifier:

NCT05962684

Other Study ID Numbers:

ERAS Craniotomy

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elena Arnaoutoglou, Professor in Anesthesiology, University of Thessaly

ERAS

Craniotomy

Perioperative management

Study Results

No Results Posted as of Jul 27, 2023