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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03668262
Other study ID # CINI-AD-20180808
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2018
Est. completion date January 30, 2019

Study information

Verified date January 2020
Source China International Neuroscience Institution
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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".


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".


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria:

1. ASA ?~?level;

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cis-atracurium
Different concentration of cis-atracurium

Locations

Country Name City State
China Xuanwu Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
China International Neuroscience Institution

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laryngeal mask insertion conditions(satisfactory/unsatisfactory) 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. through study completion, an average of 1 day
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