Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Phase 4

Completed

• Conditions: Postoperative Respiratory Condition
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT02243943
• Lead Sponsor: Leiden University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Results First Submitted: 2016-07-14
• Results First Submitted QC: 2016-07-14
• Results First Posted: 2016-08-25
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-11
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	Subjects in this arm will be reversed with sugammadex 2-4 mg/kg
neostigmine	Neostigmine	subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Primary Outcome Measures

Name	Time	Method
Mean Lowest Saturation	45 minutes post surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Leiden Medical University; 🇳🇱 Leiden, Zuid Holland, Netherlands