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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yon Hee Shim, Yonsei University
ClinicalTrials.gov Identifier:
NCT01524367
First received: October 28, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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
Agitation
Drug: saline
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.


Estimated Enrollment: 74
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524367

Contacts
Contact: Yonhee Shim, MD, PhD 02-2019-6808
Contact: Jieun Kim, MD 02-2019-6080

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

No publications provided

Responsible Party: Yon Hee Shim, MD, PhD, Yonsei University
ClinicalTrials.gov Identifier: NCT01524367     History of Changes
Other Study ID Numbers: 3-2011-0200
Study First Received: October 28, 2011
Last Updated: February 2, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014