Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile (Neuropa)

Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit

Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.

Study Overview

• Status: Completed
• Conditions: Postoperative Respiratory Condition
• Intervention / Treatment: Drug: Neostigmine; Drug: Sugammadex

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands, 2333ZA
      • Leiden Medical University

Participation Criteria

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:

• Age 18 years
• - BMI < 35
• -ASA class I- III

• -Patients scheduled for surgery requiring general anesthesia with the use of NMBA's

  • Patients with ability to give oral and written informed consent

Exclusion Criteria:

• Failure to meet the inclusion criteria

  • -Known or suspected neuromuscular disorders impairing neuromuscular function
  • -Allergies to muscle relaxants, anesthetics or narcotics

• A (family) history of malignant hyperthermia

  • -Women who are or may be pregnant or are currently breast feeding
  • -Contraindications for the use of neostigmine
• Intestinal obstruction,

• COPD GOLD 4

  • -Abnormal heart rhythm (eg. bradycardia: < 40/min);
  • -Surgery requiring neuraxial anesthesia / analgesia
  • -Preoperative cognitive dysfunction or mental disabilities
  • -Preexistent significant pulmonary disease with preoperative SpO2 < 90%
  • -Preoperative ICU treatment / intubation (ICU patient);
  • -Need for postoperative ICU treatment or ventilation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex; Subjects in this arm will be reversed with sugammadex 2-4 mg/kg	Drug: Sugammadex; Other Names: Bridion
Active Comparator: neostigmine; subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg	Drug: Neostigmine; Other Names: Prostigmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Lowest Saturation	Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery	45 minutes post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	using the 1-10 numeric rating scale	45 minutes post surgery
Sedation	using the Leiden observer alertness score (1 alert - 5 sedated)	45 minutes post surgery

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Albert Dahan, MD, PhD, Professor, Leiden Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: respiratory failure; Neuromuscular block; neuromuscular reversal; postoperative conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: NL34186.058.10 (Other Identifier: LUMC)