Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.

Phase 1

• Conditions: Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005156-26-ES
• Lead Sponsor: Dr. Enrique Alday

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who previously signed informed consent.
Patients undergoing one of the following interventions:
-Segmental hepatectomy, atypical or lobar.
-Whipple pancreaticoduodenectomy cephalic and type reconstruction.
-Pancreatic resection without reconstruction
-Splenectomy.
-Partial or total gastrectomy
Partial or total colectomy with or without reconstruction transit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

? Do not give your consent.
? Come to the recovery unit mechanical ventilation.
? Have hypersensitivity reactions to any of the study drugs.
? A history of severe asthma or moderate asthma treated.
? Have a history of pulmonary fibrosis or very severe COPD (grade IV ranking GOLD).
? Have had myocardial infarction or coronary occlusion the three months prior to surgery.
? Have Myasthenia Gravis.
? Please specify emergency surgery.
? neuromuscular blockade was performed with non-steroidal blockers do not require pharmacological reversal of blockade.
? Do not have an epidural catheter for postoperative pain control.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade.;Secondary Objective: Differences in the size of atelectasis measured by planimetry.<br>Differences in pO2 / FiO2 ratio in the first hour after surgery.<br>Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Primary end point(s): The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).;Timepoint(s) of evaluation of this end point: difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Differences in the size of atelectasis measured by planimetry.<br>Differences in the relationship pO2 / FiO2 in the first hour after surgery.<br>Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters;Timepoint(s) of evaluation of this end point: Differences in the size of atelectasis measured by planimetry.<br>Differences in the relationship pO2 / FiO2 in the first hour after surgery.<br>Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters