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

NCT03668262 | Completed

• 1 other identifier: CINI-AD-20180808
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.The dosages of muscle relaxants used in various researches vary greatly.
3. 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".

Conditions

Urologic Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

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

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

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

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

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

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

Interventions

Cis-atracurium DRUG

Different concentration of cis-atracurium

Also known as: muscle relaxants

0.02mg/ kg group; 0.03mg/ kg group; 0.05mg/ kg group; 0.07mg/ kg group; 0.15mg/ kg group; 0.1mg/ kg group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Neuromuscular diseases or metabolic diseases;
• Preoperative complicated with water and electrolytes disorders ( such as hypokalemia and hypocalcemia );
• Serious hepatic and renal insufficiency and serious heart and lung diseases;
• Predictable difficult airway;
• 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;
• Muscle relaxation drug allergy;
• Previous history of alcoholism or drug abuse.

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• Wang X, Huang K, Yan H, Lan F, Yao D, Li Y, Xue J, Wang T. The median effective dose (ED50) of cis-Atracurium for laryngeal mask airway insertion during general Anaesthesia for patients undergoing urinary surgery. BMC Anesthesiol. 2020 Mar 19;20(1):68. doi: 10.1186/s12871-020-00982-3.

  PMID: 32192431 DERIVED

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 12, 2018
• Study Start: September 15, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)