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Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

This study has been completed.
Information provided by (Responsible Party):
Yon Hee Shim, Yonsei University Identifier:
First received: October 28, 2011
Last updated: February 4, 2015
Last verified: February 2015

Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.

Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.

Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.

To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.

The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).

Condition Intervention Phase
Drug: saline
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • severity of emergence excitement based on Richmond agitation-sedation scale [ Time Frame: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours. ]
    The severity of emergence excitement will be measured up to 10 minutes after extubation based on Richmond agitation-sedation(time of eye opening on command, time of leaving the operation room, 5 minutes after arriving post anesthetic recovery room, 10 minutes after extubation).

Secondary Outcome Measures:
  • emergence time [ Time Frame: up to the time of eye opening,an expected average of 30 minutes. ]
    The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.

  • coughing grade [ Time Frame: up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours. ]
    The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.

Enrollment: 74
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline group
We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing.
Drug: saline
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
Other Name: normal saline
Experimental: dexmedetomidine group
We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing.
Drug: Dexmedetomidine
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
Other Name: Precedex


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA physical status 1 or 2 patients
  • patients scheduled for orthognathic surgery (two-jaw)

Exclusion Criteria:

  • severe cardiovascular disease
  • allergy to dexmedetomidine
  • psychological disease
  • patients who cannot understand Korean
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Please refer to this study by its identifier: NCT01524367

Korea, Republic of
Gangnam severance hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Study Director: Yonhee Shim Yonsei University
  More Information

Responsible Party: Yon Hee Shim, MD, PhD, Yonsei University Identifier: NCT01524367     History of Changes
Other Study ID Numbers: 3-2011-0200
Study First Received: October 28, 2011
Last Updated: February 4, 2015

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017