General Versus Regional Anaesthesia in Peripheral Arterial Surgery: Incidence of Postoperative Pulmonary Complications.

NCT04566016 | Unknown DMC

• 2 other identifiers: 95165518.6.0000.5327RBR-72fpz2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be designed as a prospective clinical trial. Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).

Conditions

Peripheral Vascular Diseases

Keywords

postoperative pulmonary complications; vascular surgery; regional anesthesia; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications.

  To evaluate the effects of spinal neuroaxial anesthesia under spontaneous ventilation (group 1) in relation to general anesthesia under mechanical ventilation (group 2) on the incidence of pulmonary complications (primary endpoint composed: mild respiratory failure / hypoxemia, severe respiratory failure, suspected pulmonary infection , atelectasis, acute lung injury, barotrauma, pulmonary infiltrate, pleural effusion, bronchospasm, cardiopulmonary edema, acute respiratory distress syndrome - ARDS) in the perioperative period of patients undergoing lower limb bypass surgery.

  7 days

Secondary Outcomes (5)

• Incidence of hemodynamic complications (secondary outcome consisting of distributive shock or persistent hypotension requiring use of vasoactive drugs)

  7 days

• Incidence of minor ventilatory complications related to the ventilation strategy (desaturation) in the intraoperative period.

  7 days

• Perioperative pulmonary, gasometric and inflammatory physiological parameters.

  7 days

• Hemodynamic parameters in the perioperative period.

  7 days

• Incidence of various extrapulmonary complications, in-hospital mortality, length of stay in the post-recovery room -anesthetic, and length of hospital stay.

  7 days

Study Arms (2)

Regional anesthesia

EXPERIMENTAL

Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1).

Procedure: Regional anesthesia

General anesthesia

ACTIVE COMPARATOR

Patients scheduled for lower limb arterial bypass surgery and allocated for treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).

Procedure: Regional anesthesia

Interventions

Regional anesthesia PROCEDURE

Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).

Also known as: Spinal anesthesia

General anesthesia; Regional anesthesia

Eligibility Criteria

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

You may qualify if:

• Adult patients ASA II to IV; age greater than 18 years; scheduled for arterial revascularization surgery on lower limbs.

You may not qualify if:

• Patients with a body mass index above 40 kg / m2 who underwent emergency surgery, with a history of pulmonary surgery, persistent hemodynamic instability in the preoperative period, history of asthma or chronic use of corticotherapy, or patients with history neuromuscular disorder. Patients with a history of use of anticoagulants or antiplatelet agents in the preoperative period who contraindicate the performance of spinal anesthesia will also be excluded from the study. In this study, only patients with peripheral vascular disease with critical and symptomatic ischemia in the lower limbs and scheduled to undergo elective arterial revascularization of the lower limbs will be included, and all patients with acute vascular obstruction or other associated vascular complications will be excluded.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Andre Prato Schmidt

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Anesthesia, Conduction; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Andre P Schmidt

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Cristiano F Andrade

  Hospital de Clinicas de Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel controlled trial.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: February 28, 2019
• Primary Completion: December 31, 2021
• Study Completion: July 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)