Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

NCT ID: NCT01966484

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with neostigmine. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), patient satisfaction and the postoperative performance with respiration exercise device for these two muscle relaxants.

Detailed Description

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Conditions

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Intubating Conditions Performance With Respiratory Exercise Device Postoperative Myalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Succinylcholine

Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.

Group Type ACTIVE_COMPARATOR

Succinylcholine

Intervention Type DRUG

Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.

Mivacurium

Patients receive mivacurium (0,08mg/kg) as a muscle relaxant after induction of general anaesthesia for rigid bronchoscopy. At the end of the procedure and a twitch of 25% mivacurium was reversed with neostigmine (50 microg/kg) and atropin (10 microg/kg)

Group Type ACTIVE_COMPARATOR

Mivacurium

Intervention Type DRUG

Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.

Interventions

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Succinylcholine

Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.

Intervention Type DRUG

Mivacurium

Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.

Intervention Type DRUG

Other Intervention Names

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Mivacurium Rigid Bronchoscopy Succinylcholine Rigid Bronchoscopy

Eligibility Criteria

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Inclusion Criteria

* age \> 18 yr
* scheduled for elective rigid bronchoscopy

Exclusion Criteria

* known neuromuscular disease
* significant hepatic or renal dysfunction
* family history of malignant hyperthermia
* known allergy to one of the drugs used in this protocol
* pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Horst Schmidt Klinik GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grietje Beck, Prof

Role: STUDY_CHAIR

Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany

Locations

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Dr. Horst Schmidt Klinik GmbH

Wiesbaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HSK003

Identifier Type: -

Identifier Source: org_study_id

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