Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

Not Applicable

Suspended

• Conditions: Patient Satisfaction; Intubating Conditions; Postoperative Myalgia
• Interventions: Drug: Rocuronium 0,6; Drug: Rocuronium 0,3; Drug: Succinylcholine

• Registration Number: NCT01996358
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief Summary

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-11-27
• Study Start: 2015-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age > 18 yr
• scheduled for elective rigid bronchoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium 0,6	Rocuronium 0,6	Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Rocuronium 0,3	Rocuronium 0,3	Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Succinylcholine	Succinylcholine	Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy

Primary Outcome Measures

Name	Time	Method
Intubating Condition	after induction of general anaesthesia (after 3-5 minutes)	The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing

Secondary Outcome Measures

Name	Time	Method
Postoperative Myalgia	72 hours after intervention	The severity of POM is measured by using a four-point-scale: 0. no myalgia; 1. minor pain limited to one area of the body; 2. muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy; 3. generalized, severe or incapacitating discomfort

Trial Locations

Locations (1)

Dr. Horst Schmidt Klinik; 🇩🇪 Wiesbaden, Hessen, Germany