Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Respiratory Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugammadex

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

neostigmine

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

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Interventions

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Sugammadex

Intervention Type DRUG

Neostigmine

Intervention Type DRUG

Other Intervention Names

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Bridion Prostigmin

Eligibility Criteria

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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

* -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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No