Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia

NCT06360666 | Enrolling By Invitation DMC

• 1 other identifier: Neurax1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mortality; Surgical Complication; Neurological Complication; Respiratory Complication; Cardiovascular Complication; Nephrotoxicity; Metabolic Complication

Keywords

awareness; locoregional anesthesia; general anesthesia; laparoscopic abdominal surgery

Outcome Measures

Primary Outcomes (2)

• Mortality

  To determine the rate of postoperative mortality within the two patient cohorts

  90 days

• Morbidity

  To determine the number of postoperative length of stay days within the two patient cohorts

  90 days

Secondary Outcomes (2)

• Surgical revisions

  90 days

• organ dysfunctions

  90 days

Study Arms (2)

General Anesthesia

Patients undergoing elective laparoscopic major surgery in general anesthesia

Loco Regional Anesthesia - Awareness

Patients undergoing elective laparoscopic major surgery using a combined subarachnoid and thoracic epidural anesthesia approach, keeping the patient spontaneously breathing

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

Patients considered for the study will be those undergoing elective laparoscopic major surgery, enrolled in the clinical database for follow-up by the Anesthesia and Intensive Care Unit and General Surgery Unit at the Vizzolo facility - ASST Melegnano e Martesana.

You may qualify if:

• Age \>18 years
• "ASA physical status"\>1 (ASA=American Society of Anesthesiologists)
• METs\<10 (MET= Metabolic Equivalent)

You may not qualify if:

• "ASA physical status"=1
• METs≥10
• patients undergoing laparotomy or emergency surgery, presenting contraindications to central locoregional anesthesia execution (specifically: coagulation disorders, severe spinal malformations, known allergy to local anesthetics, severe aortic stenosis, systemic sepsis, puncture site infection)

Sponsors & Collaborators

• Asst Melegnano e Martesana: lead

Study Sites (1)

ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi

Vizzolo Predabissi, Milan, 20070, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2024
• Study Start: October 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)