NCT02108171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

March 30, 2014

Results QC Date

February 10, 2015

Last Update Submit

February 13, 2016

Conditions

Benign Neoplasm of Vocal Fold - Glottis

Keywords

intranasaldexmedetomidineearly recoverysuspension laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine

    1 days

  • Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine

    1 day

  • 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

  • +5 more secondary outcomes

Other Outcomes (67)

  • Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo

    1 day

  • Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine

    1 day

  • Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo

    1 day

  • +64 more other outcomes

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

intranasal dexmedetomidine

Drug: Dexmedetomidine

placebo

PLACEBO COMPARATOR

intranasal saline

Drug: placebo

Interventions

DexmedetomidineDRUG

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.

Also known as: intranasal dexmedetomidine
dexmedetomidine
placeboDRUG

0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.

Also known as: saline
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

Location

Related Publications (9)

  • 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.

    PMID: 24237879BACKGROUND

  • 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.

    PMID: 17646493BACKGROUND

  • 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.

    PMID: 22950484BACKGROUND

  • 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.

    PMID: 21685111BACKGROUND

  • 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.

    PMID: 21318594BACKGROUND

  • 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.

    PMID: 23497981BACKGROUND

  • 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.

    PMID: 23325950BACKGROUND

  • 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.

    PMID: 20645951BACKGROUND

  • 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.

    PMID: 27196121DERIVED

MeSH Terms

Interventions

DexmedetomidineSodium Chloride

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Xiangcai Ruan
Organization
Guangzhou First People's Hospital, Affiliated Hospital of Guangzhou Medical College
xc_ruan@hotmail.com
+8620-81048306

Study Officials

  • Xiangcai Ruan, MD, PHD

    Guangzhou First Municipal People's Hospital,Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chair

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 9, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 14, 2016

Results First Posted

March 14, 2016

Record last verified: 2016-02

Locations

CN(2)