Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

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

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.

Study Overview

• Status: Suspended
• Conditions: Patient Satisfaction; Intubating Conditions; Postoperative Myalgia
• Intervention / Treatment: Drug: Succinylcholine; Drug: Rocuronium 0,3; Drug: Rocuronium 0,6

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Wiesbaden, Hessen, Germany, 65199
      • Dr. Horst Schmidt Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Succinylcholine; Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy	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.
Active Comparator: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	measurement on a numeric ten point scale	72 hours after intervention

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH
• Investigators: Study Chair: Grietje Beck, Prof, Dr. Horst Schmidt Klinik

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Rocuronium; Succinylcholine; Rigid Bronchoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Rocuronium; Succinylcholine
• Other Study ID Numbers: HSK004