A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Extubation Time After Intranasal Dexmedetomidine Premedication
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Sleep apnea syndrome
- •Liver and kidney dysfunction
- •Known to suffer from mental illness
- •Long-term use of sedatives and analgesics in patients
Arms & Interventions
dexmedetomidine
intranasal dexmedetomidine
Intervention: Dexmedetomidine (Drug)
placebo
intranasal saline
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Extubation Time After Intranasal Dexmedetomidine Premedication
Time Frame: 1 days
The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration
Secondary Outcomes
- Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine(1 day)
- Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine(1 days)
- Number of Participants With Anxiety Score >2(1 day)
- Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine(1 day)
- Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine(1 day)
- Number of Participants With Satisfaction Score <2(1 day)
- Perioperative Bradycardia Episodes(1 day)
- Perioperative Tachycardia Episodes(1 day)
- Perioperative Hypotension Episodes(1 day)
- Perioperative Hypertonsion Episodes(1 day)
Investigators
Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain
Vice Chair
Guangzhou First People's Hospital