Intranasal Dexmedetomidine Premedication

Guangzhou First People's Hospital

Status

Completed

Conditions

Benign Neoplasm of Vocal Fold - Glottis

Treatments

Drug: Dexmedetomidine

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02108171

GZFPH-IRB-2013-086

Details and patient eligibility

About

Most patients with preoperative varying degrees of stress, anxiety, which makes the stress response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic system hyperexcitability prone to cause adverse cardiovascular events and affect postoperative recovery. However, phenobarbital, as the traditional premedication, has less sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative, anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore, dexmedetomidine as premedication has certain advantages. The purpose of this research is to study sedative effect, safety and the impact of anesthesia recovery period of intranasal dexmedetomidine premedication for suspension laryngoscopy.

Full description

All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45 min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score and anxiety levels regularly assessed. Patients with general anesthesia, suspension laryngoscopy surgery and postoperative care, standard monitoring are unified.

Enrollment

81 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Surgery:The laryngoscope vocal polyp excision
Aged 18 to 60 years old
Body mass index (BMI) < 30 kg/m2
American society of Anesthesiologist (ASA) I -II

Exclusion criteria

The investigator refused to participate
Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
With previous history of heart disease
Pregnant women; no reliable contraceptive measures in postmenopausal women
Preoperative heart rate less than 45bpm; Ⅱ or Ⅲ degree atrioventricular block; ischemic heart disease
Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
Asthma
Sleep apnea syndrome
Liver and kidney dysfunction
Known to suffer from mental illness
Long-term use of sedatives and analgesics in patients