Intranasal Dexmedetomidine Premedication

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy

Conditions
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Benign Neoplasm of Vocal Fold - Glottis

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine<br>intranasal dexmedetomidine | Drug: Dexmedetomidine<br>* intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.<br>* Other names: intranasal dexmedetomidine;|
| Placebo Comparator: placebo<br>intranasal saline | Drug: placebo<br>* 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation Time After Intranasal Dexmedetomidine Premedication | The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration | 1 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine | Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine. Modified Observer's Assessment of Alertness/Sedation Scale: 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking 1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus. | 1 days | 
| Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine | Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study. | 1 day | 
| Number of Participants With Anxiety Score >2 | satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction. Anxiety score >2 was considered to be better for the patient. | 1 day | 
| Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine | 4-point anxiety score: = combative = anxious = calm = amiable. Anxiety score >2 was considered to be better for the preoperative patients. | 1 day | 
| Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine | Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine. | 1 day | 
| Number of Participants With Satisfaction Score <2 | Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU). Satisfaction score <2 was considered to be better for the patient | 1 day | 
| Perioperative Bradycardia Episodes | Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s. | 1 day | 
| Perioperative Tachycardia Episodes | Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s. | 1 day | 
| Perioperative Hypotension Episodes | Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min. | 1 day | 
| Perioperative Hypertonsion Episodes | Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal, dexmedetomidine, early recovery, suspension laryngoscopy