Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Postoperative Respiratory Condition Clinical Trial

— Neuropa  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243943
• Other study ID #: NL34186.058.10
• Secondary ID: NL34186.058.10
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2014
• Last updated: December 6, 2015
• Start date: September 2014

Study information

• Verified date: December 2015
• Source: Leiden University Medical Center
• Contact: Albert Dahan, MD, PhD, Professor
• Phone: +31715262301
• Email: a.dahan[@]lumc.nl
• Is FDA regulated: No
• Health authority: Medical Ethics Review Committee (METC): The NetherlandsMinistry of Health, Welfare and Sport: The Netherlands
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Respiratory Condition

Intervention

Drug:
• Sugammadex

• Neostigmine

Locations

Country	Name	City	State
Netherlands	Leiden Medical University	Leiden	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 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	No
Secondary	lowest saturation	Lowest saturation is the lowest Hb-oxygen saturation measured by finger pulse oximeter as observed in the first 45 min in the recovery room following surgery	45 minutes	No
Secondary	respiratory rate		45 minutes	No
Secondary	Pain	using the 1-10 numeric rating scale	45 minutes	No
Secondary	sedation	using the Leiden observer alertness score	45 minutes	No
Secondary	supplemental oxygen	need for supplemental oxygen	45 minutes	No