Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Fujian Provincial Hospital
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital
ClinicalTrials.gov Identifier:
NCT01895023
First received: June 28, 2013
Last updated: December 12, 2013
Last verified: May 2013
  Purpose

Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families.

Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.


Condition Intervention Phase
Inhalational Anesthetics Adverse Reaction
Delirium on Emergence
Strabismus Following Ocular Surgery
Drug: Dexmedetomidine
Drug: Midazolam
Drug: Saline
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: Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children

Resource links provided by NLM:


Further study details as provided by Fujian Provincial Hospital:

Primary Outcome Measures:
  • Emergence agitation [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ] [ Designated as safety issue: Yes ]

    Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.

    A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.



Secondary Outcome Measures:
  • Postoperative vomiting [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
    Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more


Other Outcome Measures:
  • Children's pain [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ] [ Designated as safety issue: No ]
    A Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) was used to measure five categories of pain related behaviour, each scored from 0, 1 or 2, for a maximum score of 10.

  • Time of emergence [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    the time to the first response to a simple verbal command

  • Duration of PACU stay [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ] [ Designated as safety issue: No ]
    The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort.


Estimated Enrollment: 156
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine group
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Drug: Dexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Other Name: alpha2-adrenoceptor agonist
Active Comparator: Midazolam group
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Drug: Midazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Other Name: GABA modulators
Placebo Comparator: Placebo Group
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Drug: Saline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Other Name: sodium chloride injection (0.9%Nacl)

Detailed Description:

Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.

A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

Exclusion Criteria:

  • mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
  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: NCT01895023

Contacts
Contact: Yusheng Yao, M.D. 86-13559939629 fjslyys@gmail.com

Locations
China, Fujian
Fujian Provincial Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Yusheng Yao, M.D.    86-13559939629    fjslyys@gmail.com   
Sponsors and Collaborators
Yao Yusheng
West China Hospital
Investigators
Principal Investigator: Yusheng Yao, M.D. Fujian Provincial Hospital
  More Information

No publications provided

Responsible Party: Yao Yusheng, Dr., Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT01895023     History of Changes
Other Study ID Numbers: FujianPH-TRC-130615
Study First Received: June 28, 2013
Last Updated: December 12, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Strabismus
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Ocular Motility Disorders
Dexmedetomidine
Midazolam
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on October 22, 2014