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ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia

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ClinicalTrials.gov Identifier: NCT03668262
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
China International Neuroscience Institution

Brief Summary:
  1. The muscle relaxants can improve the conditions of laryngeal mask incubation and reduce the related complications (such as laryngeal spasm and postoperative throat pain)
  2. The dosages of muscle relaxants used in various researches vary greatly.
  3. We are planning use the most classical method for determining the ED50 or half effective concentration of cis-atracurium using sequential method, which is also called " up and down method" and " ladder method".

Condition or disease Intervention/treatment
Urologic Diseases Drug: Cis-atracurium

Detailed Description:
The concordance of the current research is that muscle relaxants can improve the conditions of laryngeal mask incubation and reduce the related complications (such as laryngeal spasm and postoperative throat pain ) of laryngeal mask incubation. It is necessary to use muscle relaxants in laryngeal mask incubation under non-special circumstances. However, the dosages of muscle relaxants used in various researches vary greatly of normal endotracheal intubation. Previous studies have shown that the amount of muscle relaxant required for laryngeal mask intubation is smaller than that required for endotracheal intubation. Although the dosage of muscle relaxant required for tracheal intubation can ensure the smooth insertion of laryngeal mask airway, laryngeal mask airway is mostly used for short surgery, which is prone to postoperative muscle relaxation residue and prolongs the recovery. We planning use the most classical method for determining the ED50 or half effective concentration of cis-atracurium using sequential method, which is also called " up and down method" and " ladder method".

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Study Type : Observational [Patient Registry]
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: ED50 of Cis-atracurium for Laryngeal Mask Incubation in General Anesthesia During Urology Surgery
Actual Study Start Date : September 15, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
0.15mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants

0.1mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. 0.15/1.5=0.1 ( If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants

0.07mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. 0.1/1.5=0.0667 ( If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants

0.05mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. 0.07/1.5=0.0466( If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants

0.03mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. 0.05/1.5=0.0333 ( If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants

0.02mg/ kg group
Administration method of cis-atracurium: the dose of the first patient is 0.15 mg / kg, and the ratio between adjacent doses is 1.5. 0.03/1.5=0.02( If the laryngeal mask insertion condition of this patient is satisfactory, the next patient will use the lower dose. If the laryngeal mask insertion condition of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)
Drug: Cis-atracurium
Different concentration of cis-atracurium
Other Name: muscle relaxants




Primary Outcome Measures :
  1. Laryngeal mask insertion conditions(satisfactory/unsatisfactory) [ Time Frame: through study completion, an average of 1 day ]
    The evaluation criteria of laryngeal mask insertion conditions are based on siva lingam's six-point three-level table, which is evaluated from the following six aspects: the degree of mouth opening, difficulty in laryngeal mask insertion, cough, retch, laryngeal spasm, and body movement. Each item is divided into 3, 2 and 1 points according to the degree of severity, with a full score of 18 points, 16 points and above being satisfactory, and 16 points and below being unsatisfactory.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients in Xuanwu Hospital for elective short urological surgery are selected.

One day before surgery, visitors recorded basic information such as the patient's sex, age, BMI, ASA grade in the ward, carried out airway evaluation, and recorded the mouth opening to make sure they can be included

Criteria

Inclusion Criteria:

  1. ASA Ⅱ~Ⅲlevel;
  2. BMI18.5-30;
  3. Those who intend to undergo short urological surgery ( operation time < 1h );
  4. Age 25~75 years
  5. Estimated amount of bleeding < 5ml / kg.

Exclusion Criteria:

  1. Neuromuscular diseases or metabolic diseases;
  2. Preoperative complicated with water and electrolytes disorders ( such as hypokalemia and hypocalcemia );
  3. Serious hepatic and renal insufficiency and serious heart and lung diseases;
  4. Predictable difficult airway;
  5. Take drugs ( such as aminoglycoside, polymyxin, phenytoin sodium, carbamazepine, etc. ) that affect the nerve-muscle transmission function or the efficacy of muscle relaxants before surgery;
  6. Muscle relaxation drug allergy;
  7. Previous history of alcoholism or drug abuse.

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): NCT03668262


Locations
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China, Beijing
Xuanwu Hospital
Beijing, Beijing, China, 100053
Sponsors and Collaborators
China International Neuroscience Institution
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: China International Neuroscience Institution
ClinicalTrials.gov Identifier: NCT03668262    
Other Study ID Numbers: CINI-AD-20180808
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urologic Diseases
Atracurium
Cisatracurium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action