Clinical trial NCT02108171: Intranasal Dexmedetomidine Premedication
Official title: A Randomised Controlled Trial of Intranasal Dexmedetomidine as Premedication for Suspension Laryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Neoplasm of Vocal Fold - Glottis
Keywords: intranasal
dexmedetomidine
early recovery
suspension laryngoscopy
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Extubation Time After Intranasal Dexmedetomidine Premedication
timeFrame: 1 days
Secondary outcomes:
measure: Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 days
measure: Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 day
measure: Number of Participants With Anxiety Score >2
timeFrame: 1 day
measure: Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 day
measure: Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 day
measure: Number of Participants With Satisfaction Score <2
timeFrame: 1 day
measure: Perioperative Bradycardia Episodes
timeFrame: 1 day
measure: Perioperative Tachycardia Episodes
timeFrame: 1 day
measure: Perioperative Hypotension Episodes
timeFrame: 1 day
measure: Perioperative Hypertonsion Episodes
timeFrame: 1 day
Other outcomes:
measure: Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 day
measure: Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine
timeFrame: 1 day
measure: Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Duration of Anesthesia of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Duration of Surgery of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation
timeFrame: 1 day
measure: Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation
timeFrame: 1 day
measure: Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs
timeFrame: 1 day
measure: Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs
timeFrame: 1 day
measure: Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction
timeFrame: 1 day
measure: Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction
timeFrame: 1 day
measure: Satisfaction Scores of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Time to Consciousness of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Time to Extubation of Patients Receiving Intranasal Placebo
timeFrame: 1 day
measure: Time to Extubation of Patients Receiving Intranasal Dexmedetomidine
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation
timeFrame: 1 day
measure: Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation
timeFrame: 1 day
measure: HR in the Placebo Group Before Intranasal Drugs
timeFrame: 1 day
measure: HR in the Dexmedetomidine Group Before Intranasal Drugs
timeFrame: 1 day
measure: HR in the Placebo Group at Pre-induction
timeFrame: 1 day
measure: HR in the Dexmedetomidine Group at Pre-induction
timeFrame: 1 day
measure: Number of Participants With VAS >50
timeFrame: 1 day
measure: Patients With Postoperative Nausea in Two Groups
timeFrame: 1 day
measure: Patients With Postoperative Vomiting in Two Groups
timeFrame: 1 day
measure: Patients With Postoperative Shivering in Two Groups
timeFrame: 1 day
measure: Patients With Intra-operative Awareness in Two Groups
timeFrame: 1 day
measure: Visual Analogue Scale (VAS) in the Placebo Group
timeFrame: 1 day
measure: Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group
timeFrame: 1 day
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
Study officials:
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou Medical College
name: Xiangcai Ruan, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheta SA, Al-Sarheed MA, Abdelhalim AA. Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial. Paediatr Anaesth. 2014 Feb;24(2):181-9. doi: 10.1111/pan.12287. Epub 2013 Nov 15.
citation: Yuen VM, Irwin MG, Hui TW, Yuen MK, Lee LH. A double-blind, crossover assessment of the sedative and analgesic effects of intranasal dexmedetomidine. Anesth Analg. 2007 Aug;105(2):374-80. doi: 10.1213/01.ane.0000269488.06546.7c.
citation: Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.
citation: Cheung CW, Ng KF, Liu J, Yuen MY, Ho MH, Irwin MG. Analgesic and sedative effects of intranasal dexmedetomidine in third molar surgery under local anaesthesia. Br J Anaesth. 2011 Sep;107(3):430-7. doi: 10.1093/bja/aer164. Epub 2011 Jun 16.
citation: Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.
citation: Nooh N, Sheta SA, Abdullah WA, Abdelhalim AA. Intranasal atomized dexmedetomidine for sedation during third molar extraction. Int J Oral Maxillofac Surg. 2013 Jul;42(7):857-62. doi: 10.1016/j.ijom.2013.02.003. Epub 2013 Mar 14.
citation: Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
citation: Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.
citation: Lu C, Zhang LM, Zhang Y, Ying Y, Li L, Xu L, Ruan X. Intranasal Dexmedetomidine as a Sedative Premedication for Patients Undergoing Suspension Laryngoscopy: A Randomized Double-Blind Study. PLoS One. 2016 May 19;11(5):e0154192. doi: 10.1371/journal.pone.0154192. eCollection 2016.