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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668262
• Other study ID #: CINI-AD-20180808
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Urologic Diseases

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