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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01895023
Other study ID # FujianPH-TRC-130615
Secondary ID
Status Completed
Phase Phase 4
First received June 28, 2013
Last updated January 2, 2015
Start date September 2013
Est. completion date August 2014

Study information

Verified date January 2015
Source Fujian Provincial Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 6 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Midazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Saline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia

Locations

Country Name City State
China Fujian Provincial Hospital Fuzhou Fujian

Sponsors (2)

Lead Sponsor Collaborator
Yao Yusheng West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Children's pain 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. participants will be followed for the duration of PACU stay, an expected average of 1 hour No
Other Time of emergence the time to the first response to a simple verbal command up to 1 hour No
Other Duration of PACU stay The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort. participants will be followed for the duration of PACU stay, an expected average of 1 hour No
Primary Emergence agitation 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.
participants will be followed for the duration of PACU stay, an expected average of 1 hour Yes
Secondary Postoperative vomiting Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more up to 24 hours Yes
See also
  Status Clinical Trial Phase
Completed NCT04816162 - Ketofol for Preventing Postoperative Delirium in Elderly Patients Phase 4
Active, not recruiting NCT01901588 - Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery Phase 4
Completed NCT02509221 - Effect of Duration of Exposure of Anesthesia With Sevoflurane on Emergence Delirium
Completed NCT02489734 - Post Extubation Delirium and End-tidal Sevoflurane Concentration N/A
Completed NCT01680471 - A Study on the Effects of Midazolam on Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery N/A
Recruiting NCT04217915 - A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China
Terminated NCT02111447 - Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI Phase 4
Active, not recruiting NCT06176625 - Sight and Hearing Investigation Into Effects on Delirium N/A
Completed NCT03477994 - Efficacy of Dexmedetomidine Versus Clonidine to Control Delirium in Patients Undergoing CABG N/A