Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

Patient Satisfaction Clinical Trial

Official title:

Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01996358
• Other study ID #: HSK004
• Status: Suspended
• Phase: N/A
• First received: November 22, 2013
• Last updated: April 3, 2017
• Start date: August 2015

Study information

• Verified date: April 2017
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Intubating Conditions
• Myalgia
• Patient Satisfaction
• Postoperative Myalgia

Intervention

Drug:
• Succinylcholine
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.
• Rocuronium 0,3
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
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.

Locations

Country	Name	City	State
Germany	Dr. Horst Schmidt Klinik	Wiesbaden	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	measurement on a numeric ten point scale	72 hours after intervention
Primary	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	Postoperative Myalgia	The severity of POM is measured by using a four-point-scale: 0. no myalgia; minor pain limited to one area of the body; muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy; generalized, severe or incapacitating discomfort	72 hours after intervention