Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

NCT01996358 | Suspended

• 1 other identifier: HSK004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubating Conditions; Postoperative Myalgia; Patient Satisfaction

Keywords

Succinylcholine; Rocuronium; Rigid Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Intubating Condition

  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

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

Secondary Outcomes (1)

• Postoperative Myalgia

  72 hours after intervention

Other Outcomes (1)

• Patient satisfaction

  72 hours after intervention

Study Arms (3)

Succinylcholine

ACTIVE COMPARATOR

Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy

Drug: Succinylcholine

Rocuronium 0,3

ACTIVE COMPARATOR

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.

Drug: Rocuronium 0,3

Rocuronium 0,6

ACTIVE COMPARATOR

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.

Drug: Rocuronium 0,6

Interventions

Succinylcholine DRUG

Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.

Succinylcholine

Rocuronium 0,3 DRUG

General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.

Rocuronium 0,3

Rocuronium 0,6 DRUG

General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.

Rocuronium 0,6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Dr. Horst Schmidt Klinik

Wiesbaden, Hesse, 65199, Germany

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Succinylcholine

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds

Study Officials

• Grietje Beck, Prof

  Dr. Horst Schmidt Klinik

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

DE (1)