NCT01966484

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

October 17, 2013

Last Update Submit

July 29, 2014

Conditions

Intubating ConditionsPerformance With Respiratory Exercise DevicePostoperative Myalgia

Keywords

SuccinylcholineMivacuriumRigid BronchoscopyIntubating conditionsShort Procedure

Outcome Measures

Primary Outcomes (1)

  • Intubating condition

    For measuring the intubation conditions the scoring system proposed for Good clinical Research Practice using the following variables is used: conditions of inserting the rigid bronchoscope, vocal cord position and coughing

    After induction of general anaesthesia (after 3-5 minutes)

Secondary Outcomes (2)

  • Postoperative Myalgia

    72 hours after intervention

  • postintervention performance with a expiration exercise device

    72 hours after intervention

Other Outcomes (1)

  • Patient satisfaction

    72 hours after intervention

Study Arms (2)

Succinylcholine

ACTIVE COMPARATOR

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

Drug: Succinylcholine

Mivacurium

ACTIVE COMPARATOR

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)

Drug: Mivacurium

Interventions

SuccinylcholineDRUG

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.

Also known as: Mivacurium, Rigid Bronchoscopy
Succinylcholine
MivacuriumDRUG

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.

Also known as: Succinylcholine, Rigid Bronchoscopy
Mivacurium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Horst Schmidt Klinik GmbH

Wiesbaden, 65199, Germany

Location

MeSH Terms

Interventions

SuccinylcholineMivacurium

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsSuccinatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOnium CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Grietje Beck, Prof

    Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 21, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

DE(1)