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

Major Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361060
• Other study ID #: PRIN-SUGAR-2014
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2014
• Last updated: February 21, 2017
• Start date: February 2015
• Est. completion date: July 4, 2016

Study information

• Verified date: February 2017
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 4, 2016
• Est. primary completion date: July 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Drug:
• Neostigmine
40mcg/kg
• Sugammadex
4mg/kg
• Atropine
10 mcg/kg

Locations

Country	Name	City	State
Spain	Anesthesiology Service. Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Enrique Alday Muñoz

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Tusman G, Böhm 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in FVC at 1h after surgery		Basal and one hour after surgery
Secondary	Atelectasis size determined by lung ultrasound (Plannimetry)		One hour after surgery
Secondary	Atelectasis size determined by lung ultrasound (Plannimetry)		24 hours after surgery
Secondary	pO2/FiO2 <300		1 hour after surgery
Secondary	Asociation between atelectasis size and FVC	Atelectasis size (sqr cm) will me measured by planimetry	1 hour after surgery
Secondary	Asociation between atelectasis size and FVC	Atelectasis size (sqr cm) will me measured by planimetry	24 hour after surgery
Secondary	Asociation between atelectasis size and pO2/FiO2	Atelectasis size (sqr cm) will me measured by planimetry	1 hour after surgery
Secondary	Asociation between atelectasis size and pO2/FiO2	Atelectasis size (sqr cm) will me measured by planimetry	24 hour after surgery

External Links

•   European Public Assessment Report for Bridion®. London: European Agency for the Evaluation ofMedicinal Products (EMEA), Committee for Propietary Medicinal Products (CPMP).
•   labbel information Bridion®. European Agency for the Evaluation of Medicinal Products (EMEA). Acceso: octubre 2009.
•   Postoperative respiratory outcomes in laparoscopic bariatric surgery: Comparison of a prospective group of patients whose neuromuscular blockade was reverted with sugammadex and a his-torical one reverted with neostigmine
•   Sugammadex and anaphylaxis in the operating theater.