Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery

February 21, 2017 updated by: Enrique Alday Muñoz

Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery - A Randomized Controlled Trial

Pulmonary complications are relatively frequent after surgery, and can be associated with an increase in morbidity and mortality. Although there are several causative mechanisms that can lead to postoperative pulmonary complications, alterations in the shape and motion of the chest wall are of primary importance.

In the investigator´s institution the incidence of postoperatory hypoxemia defined as pO2/FiO2 <300 is over 20% for patients after major abdominal surgery.

Observational and randomized clinical trials have demonstrated that incomplete neuromuscular recovery during the early postoperative period may result in acute respiratory events (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary complications.

A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular block reversal was done with sugammadex had less chest X-ray pathological changes than those from an historical cohort reversed with neostigmine.

The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia, between patients reverted with sugammadex or neostigmine may be more apparent with more sensitive techniques like spirometry or lung ultrasound when they exist.

Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to detect alveolar consolidation in critical ill patients while chest radiography data are known to be imprecise.The investigator would like to explore the utility of LUS in postsurgical patients and the relationship between degree of hypoxemia and consolidation area.

Objectives:

  1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved in the absence of residual neuromuscular block. Objective is to assess differences after reversal with neostigmine versus sugammadex in:

    • Forced vital capacity (FVC)

  2. Secondary objectives: To assess differences after reversal with neostigmine versus sugammadex in:

    • Atelectasis size determined by lung ultrasound (Plannimetry)
    • pO2/FiO2 <300 1 hour after surgery
    • Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative atelectasis and its correlation with chest Xray, FVC and pO2/FiO2.

Hypotheses:

  1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as compared to NMB reversal with neostigmine.
  2. Atelectasis is common after major surgery. Size of atelectasis determined by lung ultrasound planimetry is lower one hour after sugammadex reversal as compared to the neostigmine group.
  3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared to the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in 20% of patients after major abdominal surgery).
  4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray after major surgery.
  5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and decrease of FVC after surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28006
        • Anesthesiology Service. Hospital Universitario La Princesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Every patient scheduled for major abdominal surgery (liver resection, pancreatectomy, gastrectomy or any type of colectomy) will be nominated to participate in the study.
  • Informed consent will be asked for after their admission to the hospital the day before the surgery.
  • Patients with postoperative epidural analgesia.

Exclusion Criteria:

  • Refusal to participate.
  • Entry to postoperative recovery unit under mechanical ventilation.
  • Hypersensitivity reactions to any of the drugs.
  • Severe asthma and mild asthma under treatment.
  • Myocardial infarction or coronary occlusion three months prior to surgery.
  • Myasthenia gravis.
  • Emergency surgery.
  • Pulmonary fibrosis or very severe chronic obstructive lung disease (GOLD IV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex
sugammadex 4 mg/kg
Drug: Sugammadex
4mg/kg
Active Comparator: Neostigmine + Atropine
Neostigmine 40µg/kg in combination with atropine 10µg/kg.
Drug: Neostigmine
40mcg/kg
Drug: Atropine
10 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in FVC at 1h after surgery
Time Frame: Basal and one hour after surgery
Basal and one hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atelectasis size determined by lung ultrasound (Plannimetry)
Time Frame: One hour after surgery
One hour after surgery
Atelectasis size determined by lung ultrasound (Plannimetry)
Time Frame: 24 hours after surgery
24 hours after surgery
pO2/FiO2 <300
Time Frame: 1 hour after surgery
1 hour after surgery
Asociation between atelectasis size and FVC
Time Frame: 1 hour after surgery
Atelectasis size (sqr cm) will me measured by planimetry
1 hour after surgery
Asociation between atelectasis size and FVC
Time Frame: 24 hour after surgery
Atelectasis size (sqr cm) will me measured by planimetry
24 hour after surgery
Asociation between atelectasis size and pO2/FiO2
Time Frame: 1 hour after surgery
Atelectasis size (sqr cm) will me measured by planimetry
1 hour after surgery
Asociation between atelectasis size and pO2/FiO2
Time Frame: 24 hour after surgery
Atelectasis size (sqr cm) will me measured by planimetry
24 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enrique Alday Muñoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 4, 2016

Study Completion (Actual)

July 4, 2016

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIN-SUGAR-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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