Last Verified: | June/30/2020 |
First Submitted: | March/25/2019 |
Estimated Enrollment Submitted: | April/3/2019 |
First Posted: | April/4/2019 |
Last Update Submitted: | July/26/2020 |
Last Update Posted: | July/27/2020 |
Actual Study Start Date: | January/27/2019 |
Estimated Primary Completion Date: | May/27/2021 |
Estimated Study Completion Date: | November/27/2021 |
Study Type: | Interventional |
Allocation: | Randomized |
: | Unicentric, randomized, blind and controlled phase IV Clinical trial of three parallel groups. Randomization: Patients will be randomized into three groups (ratio 1: 1: 1): intravenous lidocaine and paravertebral saline (group 1), intravenous and paravertebral saline solution with lidocaine (group 2) and intravenous remifentanil and paravertebral saline solution (group 3) ). The randomization will be carried out through the EPIDAT 3.1 program prior to the recruitment of the first patient and the randomization codes will be kept in a sealed envelope with the number on the outside of the envelope. Patients will be followed from the day of hospital admission until hospital discharge and after 30 days of surgery. |
Primary Purpose: | Prevention |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
: | The randomization will be carried out through the EPIDAT 3.1 program. Randomization codes will be obtained prior to the recruitment of the first patient and will be kept in a sealed envelope with numbering on the outside of the envelope. The operating room anesthesiologist will receive the assigned medication from the corresponding group with the only identification of intravenous perfusion and paravertebral perfusion, without having knowledge of the group to which the patient belongs. Bias control: The anesthesiologist responsible for the intraoperative management of the patient, the physician responsible for postoperative control in the postoperative care unit and the guard physician who will perform the cognitive dysfunction test preoperative and postoperative and the follow up until the month of surgery will be blind to the technique used, as well as those responsible for the analysis of the biological samples. |
Arm | Intervention/treatment |
---|---|
Experimental: Lidocaine IV Group 1: intravenous lidocaine and paravertebral saline (SF). In this group during intraoperative anesthetic maintenance, a continuous intravenous infusion of lidocaine at 1.5mg/kg/h until the end of surgery and perfusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1ml/kg/h will be administered. | |
Experimental: Lidocaine PV Group 2: intravenous SF and paravertebral lidocaine. During anesthesia maintenance, a continuous intravenous infusion of 0.9% SF and an infusion of 2% lidocaine will be administered through the intraoperative paravertebral catheter at a rate of 0.1 ml/kg/h. | |
Active Comparator: no lidocaine Group 3: intravenous remifentanil and paravertebral SF. During the maintenance of anesthesia, a continuous intravenous infusion of remifentanil at a rate of 0.1 mg/kg/min until the end of surgery and an infusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1 ml / kg / h. | Drug: no lidocaine intravenous remifentanil |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón hospital. - Patients who voluntarily accept to participate in the study and sign the informed consent - Age> 18 years and legally capable - Scheduled surgery. - Functional respiratory tests with forced expiratory volume at one second > 50% or forced vital capacity > 50% preoperatively performed on these patients routinely. - Not having been on chronic treatment with oral corticosteroids or immunosuppressants three months before surgery. - Patients without previous history of liver disease. Exclusion Criteria: - Pregnancy and lactation - Known hypersensitivity to amide-type local anesthetics. - Transfusion of blood products in the previous 10 days. - Impossibility of performing mechanical ventilation for pulmonary protection. |