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Major Abdominal SurgeryPhase 4NCT02361060

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

A Phase 4 study testing Neostigmine, Sugammadex and Atropine in people with Major Abdominal Surgery, run by Enrique Alday Muñoz at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Abdominal Surgery
What is being tested?
Neostigmine, Sugammadex and Atropine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesSpain
Study dates
Feb 2015to 4 Jul 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Anesthesiology Service. Hospital Universitario La Princesa

    Madrid, Madrid, 28006

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

Other trials in Spain

About this study

Official title: 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.

Read more

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)
  1. 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
Being tested
Neostigmine, Sugammadex, Atropine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeostigmineDrug

    40mcg/kg

  • SugammadexDrug

    4mg/kg

  • AtropineDrug

    10 mcg/kg

Study groups in NCT02361060
Study groupRoleWhat they receive
SugammadexExperimentalsugammadex 4 mg/kg
Receives: Drug: Sugammadex
Neostigmine + AtropineActive comparatorNeostigmine 40µg/kg in combination with atropine 10µg/kg.
Receives: Drug: Neostigmine; Drug: Atropine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in FVC at 1h after surgery

    Measured: Basal and one hour after surgery

Secondary outcomes (7)

  1. Atelectasis size determined by lung ultrasound (Plannimetry)

    Measured: One hour after surgery

  2. Atelectasis size determined by lung ultrasound (Plannimetry)

    Measured: 24 hours after surgery

  3. pO2/FiO2 <300

    Measured: 1 hour after surgery

  4. Asociation between atelectasis size and FVC

    Atelectasis size (sqr cm) will me measured by planimetry

    Measured: 1 hour after surgery

  5. Asociation between atelectasis size and FVC

    Atelectasis size (sqr cm) will me measured by planimetry

    Measured: 24 hour after surgery

  6. Asociation between atelectasis size and pO2/FiO2

    Atelectasis size (sqr cm) will me measured by planimetry

    Measured: 1 hour after surgery

  7. Asociation between atelectasis size and pO2/FiO2

    Atelectasis size (sqr cm) will me measured by planimetry

    Measured: 24 hour after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion4 Jul 2016
  4. Study completion4 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02361060
Sponsor's protocol ID
PRIN-SUGAR-2014
Status last verified
Feb 2017
First submitted
23 Dec 2014
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.

    PubMed 18385265

  • Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

    PubMed 18946293

  • Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.

    PubMed 19387176

  • Staals LM, Snoeck MM, Driessen JJ, Flockton EA, Heeringa M, Hunter JM. Multicentre, parallel-group, comparative trial evaluating the efficacy and safety of sugammadex in patients with end-stage renal failure or normal renal function. Br J Anaesth. 2008 Oct;101(4):492-7. doi: 10.1093/bja/aen216. Epub 2008 Jul 23.

    PubMed 18653492

  • Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.

    PubMed 19455040

  • Yang LP, Keam SJ. Sugammadex: a review of its use in anaesthetic practice. Drugs. 2009;69(7):919-42. doi: 10.2165/00003495-200969070-00008.

    PubMed 19441874

  • Abrishami A, Ho J, Wong J, Yin L, Chung F. Sugammadex, a selective reversal medication for preventing postoperative residual neuromuscular blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007362. doi: 10.1002/14651858.CD007362.pub2.

    PubMed 19821409

  • Ferreyra G, Long Y, Ranieri VM. Respiratory complications after major surgery. Curr Opin Crit Care. 2009 Aug;15(4):342-8. doi: 10.1097/MCC.0b013e32832e0669.

    PubMed 19542885

  • Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM; Piedmont Intensive Care Units Network (PICUN). Continuous positive airway pressure for treatment of postoperative hypoxemia: a randomized controlled trial. JAMA. 2005 Feb 2;293(5):589-95. doi: 10.1001/jama.293.5.589.

    PubMed 15687314

  • Yu CJ, Yang PC, Wu HD, Chang DB, Kuo SH, Luh KT. Ultrasound study in unilateral hemithorax opacification. Image comparison with computed tomography. Am Rev Respir Dis. 1993 Feb;147(2):430-4. doi: 10.1164/ajrccm/147.2.430.

    PubMed 8430970

  • Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.

    PubMed 20442260

  • Tusman G, Bohm SH, Warner DO, Sprung J. Atelectasis and perioperative pulmonary complications in high-risk patients. Curr Opin Anaesthesiol. 2012 Feb;25(1):1-10. doi: 10.1097/ACO.0b013e32834dd1eb.

    PubMed 22113182

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Neostigmine, Sugammadex and Atropine in people with Major Abdominal Surgery, run by Enrique Alday Muñoz at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in FVC at 1h after surgery (time frame: Basal and one hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361060, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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