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

NCT ID: NCT03668262

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-01-30

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".

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".

Conditions

Urologic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cis-atracurium

Intervention Type: DRUG

Different concentration of 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.)

Cis-atracurium

Intervention Type: DRUG

Different concentration of 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.)

Cis-atracurium

Intervention Type: DRUG

Different concentration of 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.)

Cis-atracurium

Intervention Type: DRUG

Different concentration of 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.)

Cis-atracurium

Intervention Type: DRUG

Different concentration of 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.)

Cis-atracurium

Intervention Type: DRUG

Different concentration of cis-atracurium

Interventions

Cis-atracurium

Different concentration of cis-atracurium

Intervention Type: DRUG

Other Intervention Names

muscle relaxants

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Neuroscience Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32192431 (View on PubMed)

Other Identifiers

CINI-AD-20180808

Identifier Type: -

Identifier Source: org_study_id