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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668262
Enrollment
35
Registered
2018-09-12
Start date
2018-09-15
Completion date
2019-01-30
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Diseases

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.

Interventions

Different concentration of cis-atracurium

Sponsors

China International Neuroscience Institution
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Laryngeal mask insertion conditions(satisfactory/unsatisfactory)through study completion, an average of 1 dayThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026