Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

NCT02243943 | Completed Phase 4 Results

• 1 other identifier: NL34186.058.10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Respiratory Condition

Keywords

Neuromuscular block; neuromuscular reversal; postoperative conditions; respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain

  45 minutes post surgery

• Sedation

  45 minutes post surgery

Study Arms (2)

Sugammadex

EXPERIMENTAL

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Drug: Sugammadex

neostigmine

ACTIVE COMPARATOR

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Drug: Neostigmine

Interventions

Sugammadex DRUG

Also known as: Bridion

Sugammadex

Neostigmine DRUG

Also known as: Prostigmin

neostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden Medical University

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Prof Dr A. Dahan
• Organization: LUMC

a.dahan@lumc.nl

+31 71 526 2301

Study Officials

• Albert Dahan, MD, PhD, Professor

  Leiden Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. A. Dahan

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 18, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 6, 2017
• Results First Posted: August 25, 2016

Record last verified: 2016-12

Locations

NL (1)