Fade Upon TOF Stimulation Induced by Succinylcholine

NCT02425449 | Completed Phase 4 Results

• 1 other identifier: UTIRB 200538
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle relaxants are medications used during surgery to facilitate surgical access. The effect of the muscle relaxant medications is measured by stimulation a motor nerve and measuring the force of the resultant muscle contraction. Based on the mechanism of action, two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or TOF). The nondepolarizing muscle relaxants produce fade ie successive muscle contractions are less forceful than the preceding ones. Whereas the depolarizing muscle relaxants are generally believed to produce four contractions of equal strength. However, there is some indication that this may not be entirely correct. There is evidence that depolarizing muscle relaxants also may produce fade. The investigators are conducting the following study to determine if indeed depolarizing muscle relaxants produce fade. The investigators would also like to characterize the fade ie differences during onset and offset of the block and the effect of the dose on the degree on the fade.

Conditions

Muscle Relaxants

Keywords

succinylcholine; depolarizing muscle relaxants; pharmacologic effects

Outcome Measures

Primary Outcomes (1)

• Fade on Train of Four Stimulation

  We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.

  for the duration of the effect of succinylcholine generally expected to be 6-10 minutes

Study Arms (5)

01 mg/kg

EXPERIMENTAL

Succinylcholine 0.1 mg/kg will be administered and TOF ratio measured before and after the administration until stable

Drug: Succinylcholine

0.15 mg/kg

EXPERIMENTAL

Succinylcholine 0.15 mg/kg will be administered and TOF ratio measured before and after the administration until stable

Drug: Succinylcholine

0.2 mg/kg

EXPERIMENTAL

Succinylcholine 0.2 mg/kg will be administered and TOF ratio measured before and after the administration until stable

Drug: Succinylcholine

0.25 mg/kg

EXPERIMENTAL

Succinylcholine 0.25 mg/kg will be administered and TOF ratio measured before and after the administration until stable

Drug: Succinylcholine

0.3 mg/kg

EXPERIMENTAL

Succinylcholine 0.3 mg/kg will be administered and TOF ratio measured before and after the administration until stable

Drug: Succinylcholine

Interventions

Succinylcholine DRUG

will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.

0.15 mg/kg; 0.2 mg/kg; 0.25 mg/kg; 0.3 mg/kg; 01 mg/kg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA PS I or II,
• years of age of either sex,
• with a BMI\<25Kg/m2

You may not qualify if:

• presence of any disease involving the neuromuscular system.
• Presence of any neurologic illness eg . Paraplegia or hemiplegia, spinal cord injuries, stroke, multiple sclerosis.
• No liver or kidney disease.
• Known allergy to succinylcholine.
• Family history of malignant hyperthermia.
• Known pseudocholinesterase deficiency.
• Any skin burns within the last 1 year.
• We would also exclude subjects with;
• Central core disease,
• duchenne or Becker muscular dystrophy,
• osteogenesis imperfecta,
• Noonan syndrome,
• arthrogryposis multiplex,
• congenital,
• myotonia,

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo, Health Science Campus

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Succinylcholine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shashi Bhatt, MD
• Organization: The University of Toledo

Shashi.Bhatt@utoledo.edu

419-383-3556

Study Officials

• Shashi Bhatt, MD

  University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: January 4, 2017
• Study Completion: January 4, 2017
• Last Updated: January 2, 2018
• Results First Posted: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)