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Fade Upon TOF Stimulation Induced by Succinylcholine

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ClinicalTrials.gov Identifier: NCT02425449
Recruitment Status : Completed
First Posted : April 24, 2015
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Shashi Bhatt, MD, University of Toledo Health Science Campus

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.

Condition or disease Intervention/treatment Phase
Muscle Relaxants Drug: Succinylcholine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterizing Fade Upon Train-of Four Stimulation During Onset and Offset of Neuromuscular Block Produced by Succinlycholine
Study Start Date : April 2015
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : January 4, 2017

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Arm Intervention/treatment
Experimental: 01 mg/kg
Succinylcholine 0.1 mg/kg will be administered and TOF ratio measured before and after the administration until stable
Drug: Succinylcholine
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.

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

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

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

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




Primary Outcome Measures :
  1. Fade on Train of Four Stimulation [ Time Frame: for the duration of the effect of succinylcholine generally expected to be 6-10 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA PS I or II,
  • 18-60 years of age of either sex,
  • with a BMI<25Kg/m2

Exclusion Criteria:

  • 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,
  • neuroleptic malignant syndrome,
  • multiminicore disease,
  • King Denborough syndrome,
  • Native American myopathy,
  • hypokalemic periodic paralysis or
  • a history of rhabdomyolysis.

We would also exclude any subject with a history of cardiac arrhythmias.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425449


Locations
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United States, Ohio
University of Toledo, Health Science Campus
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Shashi Bhatt, MD University of Toledo

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Responsible Party: Shashi Bhatt, MD, Associate Professor, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT02425449     History of Changes
Other Study ID Numbers: UTIRB 200538
First Posted: April 24, 2015    Key Record Dates
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shashi Bhatt, MD, University of Toledo Health Science Campus:
succinylcholine
depolarizing muscle relaxants
pharmacologic effects
Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Succinylcholine
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs