Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06360666 |
| Other study ID # |
Neurax1 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Asst Melegnano e Martesana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to learn about postoperative mortality and
postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main
question it aims to answer is:
Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the
patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery?
Participants are followed for neurological sequelae for 90 days following surgery
Description:
BACKGROUND Laparoscopic abdominal surgery has historically required general anesthesia.
However, the use of general anesthetics has neurological effects, including the risk of
postoperative neurological disorders. Cognitive impairments (amnesia, cognitive delay,
postoperative cognitive dysfunction, difficulty in resuming daily activities) occur in
variable percentages of patients based on the type and dosage of anesthetics, duration of
exposure, cerebral perfusion pressure, baseline cognitive status, and patient age. Mechanical
ventilation during general anesthesia often leads to lung atelectasis, compounded by reduced
diaphragmatic excursion due to laparoscopic insufflation, potentially impacting tissue
oxygenation and leading to postoperative complications. General anesthetics also have
negative inotropic and chronotropic effects, affecting tissue perfusion and increasing the
risk of neurological and surgical complications and cardiovascular events.
The increasing complexity of surgical techniques and patient comorbidities necessitates
exploring alternatives to general anesthesia, particularly for fragile patients undergoing
laparoscopic abdominal surgery. Regional anesthesia techniques have been advocated to provide
effective anesthesia while minimizing neurological, cardiovascular, and respiratory impacts,
thereby improving clinical outcomes and functional recovery.
RATIONALE Given the significant impact of anesthesia on postoperative complications in
fragile patients undergoing laparoscopic abdominal surgery, we aim to develop an anesthetic
strategy that optimizes clinical and functional outcomes, especially in terms of preserving
neurocognitive and respiratory function, by reducing reliance on general anesthetics. This
has led us to reconsider regional anesthesia as an alternative during laparoscopic abdominal
surgery.
STUDY DESIGN This is a retrospective observational cohort clinical study, monocentric, with
analysis of previous months (following acquisition of study consent) and follow-up.
Each patient underwent preoperative evaluation with a standard anesthesiology visit based on
national and international guidelines (SIAARTI-ERAS-ESC). Additionally, preoperative
neurologic status was assessed using the Mental Test, delirium assessment with NU-Desc, and
Frailty Scale. Lung ultrasound assessment was routinely performed on the day of surgery (see
attached assessment scores) before the start of anesthesia procedures and again 2 hours after
surgery completion. Patients were sedated with non-GABAergic anesthetics, targeting RASS
0/-2.
Data related to procedures performed, anesthetic techniques used, complications, radiological
and laboratory reports will be extracted anonymously from the Dedalus O4C, T4Health, and
TrackCare applications.
Information, in aggregated form and stratified by type of procedure, will be collected in a
Microsoft Excel database and used for subsequent statistical analysis.
FOLLOW-UP At 1 and 3 months, during routine post-operative visits, patients were assessed for
neurologic status (Mental Test, delirium assessment with NU-Desc, Frailty Scale). Mortality
was assessed at 3 months post-surgery. Patients followed at other centers were contacted by
phone to assess neurologic status and mortality.
STATISTICAL ANALYSIS Data were treated anonymously and managed using an electronic Case
Report Form (eCRF) developed with the Microsoft Excel platform. Data related to neurologic
reassessments during follow-ups are reported in the data collection sheet developed using
Microsoft Excel.
Statistical analysis will be performed using MedCalc™ version 20.118 32-bit. Appropriate
statistical tests including ANOVA, Chi-square test, and T-test will be used where applicable.
Continuous variables will be expressed as mean ± standard deviation, categorical variables as
percentages. Variables with a p-value <0.05 will be considered statistically significant.
RESULTS PUBLICATION Publication of study data will occur upon study completion.
ETHICAL/LEGAL ASPECTS
9.1 AC/CE Approval A copy of the patient's informed consent must be submitted to the Ethics
Committee (EC) along with the protocol for written approval. Written approval of the protocol
and informed consent must be obtained before patient recruitment begins.
EC favorable opinion must be obtained before the trial starts. The researcher should inform
the EC of any protocol amendments, which must be approved by the EC.
9.2 Informed Consent All eligible patients will be asked for informed consent to participate
in the study.
9.3 Personal Data Handling Personal data collected must comply with the European General Data
Protection Regulation (GDPR), Legislative Decree 196/2003 and subsequent amendments, and any
other applicable Italian laws for personal data protection ("applicable data protection
law").
The Promoter will handle personal data provided in a pseudo-anonymized form in compliance
with applicable data protection law.
The Promoter will implement necessary measures to comply with applicable data protection law
and implement appropriate technical and organizational measures to ensure GDPR compliance.
The Promoter is responsible for providing Principal Investigators and Research Personnel with
necessary information regarding how the Promoter will collect and manage their personal data
before such information is provided.
The Promoter ensures correct handling of personal data as required by the GDPR. If a data
breach involving personal data is identified, the user must promptly notify other users
within 24 hours of becoming aware of the breach. In such cases, the user must cooperate fully
to remedy the data breach, fulfill mandatory notification within specified timeframes, and
manage any resulting damage.
Data breach involving personal data is defined in articles 33 and 34 of the GDPR.
DATA COLLECTION, MANAGEMENT, AND STORAGE: CRF The study will be conducted in accordance with
the Helsinki Declaration and in compliance with good clinical practice norms (Ministerial
Decree of Health dated 15/07/1997 and subsequent amendments) and applicable regulatory
provisions.
The Promoter will appropriately maintain clinical records and research data in compliance
with section 4.9 of ICH-GCP E6, regulatory agency provisions, and institution regulations to
ensure patient confidentiality protection. As a participant in a clinical study, the Promoter
will allow authorized personnel and regulatory agencies to review (and when permitted by law,
copy) clinical records for data quality checks, audits, safety evaluations, and study
progress assessments.
Source documents include all information, original records of clinical findings,
observations, or other activities necessary for the reconstruction and evaluation of the
clinical study. Examples include but are not limited to, medical records, clinical charts,
laboratory notebooks, memoranda, patient diaries or assessment lists, drug dispensing
records, data recorded by automated instruments, certified copies or transcriptions verified
for accuracy and completeness, microfiche, photographic negatives, microfilm or magnetic
media, X-ray films, subject cards, and records kept in pharmacies, laboratories, and
technical-medical departments involved in the clinical study.
Data collection is the responsibility of personnel at the study center under the supervision
of the center's Principal Investigator. The Case Report Form (CRF) is the primary tool for
data collection. The researcher should ensure accuracy, completeness, legibility, and
timeliness of data entered into the CRF and other relevant data. Data recorded in the CRF,
derived from source documents, must match the originals, and any discrepancies should be
explained. All required CRF data must be recorded, and any missing data must be explained.
Any changes or corrections to a paper CRF must be dated, initialed by the compiler, explained
if necessary, and not obscure the original data. The researcher should track changes and
corrections made to CRFs.
The researcher/institution should maintain study documents as specified in Essential
Documents for Conducting a Clinical Study (ICH-GCP E6, section 8) and as required by
regulatory agencies and guidelines. Measures should be taken to prevent accidental or
premature destruction of documentation.
Essential documents (written and electronic) should be retained for at least fifteen (15)
years from study completion, unless the Promoter provides written authorization to dispose of
or retain data for an additional period if permitted by law, regulatory agencies, and/or
guidelines.
