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NCT Number: NCT03668262

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

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".

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Cis-Atracurium

Drug

Different concentration of cis-atracurium

Other names: muscle relaxants

Primary outcomes

  1. Laryngeal mask insertion conditions(satisfactory/unsatisfactory)

    Time frame: through study completion, an average of 1 day

    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.

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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