Muscle Relaxation for Short Procedures

Not Applicable

Completed

• Conditions: Intubating Conditions; Fasciculations; Postoperative Myalgia; Patient Satisfaction; Sore Throat
• Interventions: Drug: Rocuronium/Sugammadex; Drug: Succinylcholine; Drug: Rocuronium

• Registration Number: NCT01902641
• 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 of low-dose rocuronium, reversed by low-dose 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 Start: 2011-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Study First Posted: 2013-07-18
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocuronium/Sugammadex	Rocuronium/Sugammadex	Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.)
Succinylcholine	Succinylcholine	Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy.
Rocuronium	Rocuronium	Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fasciculations	After application of the neuromuscular blocking agent (after 3-5 min)	Fasciculations were graded by the investigator on the following four-point scale; 0 = no fasciculations; 1. = mild, fine fasciculations of the eyes, neck, face or fingers, without limb movement; 2. = moderate fasciculations occurring at more than two sites, or obvious limb movement; 3. = vigorous or severe, sustained and widespread fasciculations in the trunk and limbs
Postoperative Myalgia (POM)	72 Hours after Intervention	The severity of POM was measured 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 Kliniken; 🇩🇪 Wiesbaden, Germany