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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01524367
Collaborator
(none)
74
1
2
15
4.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (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
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Precedex
  • Outcome Measures

    Primary Outcome Measures

    1. severity of emergence excitement based on Richmond agitation-sedation scale [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

    1. emergence time [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.

    2. coughing grade [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangnam severance hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Study Director: Yonhee Shim, Yonsei University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yon Hee Shim, MD, PhD, Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01524367
    Other Study ID Numbers:
    • 3-2011-0200
    First Posted:
    Feb 2, 2012
    Last Update Posted:
    Feb 6, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 6, 2015