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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020014
Receipt No. R000023106
Scientific Title Sevoflurane Dexmedetomidine or Fentanyl in neuroanesthesia for infants, a randomised control trial
Date of disclosure of the study information 2016/06/30
Last modified on 2015/12/31

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Basic information
Public title Sevoflurane Dexmedetomidine or Fentanyl in neuroanesthesia for infants, a randomised control trial
Acronym analgesia and sedative effects of dexmedetomidine and fentanyl on infants scheduled for neurosurgical procedures
Scientific Title Sevoflurane Dexmedetomidine or Fentanyl in neuroanesthesia for infants, a randomised control trial
Scientific Title:Acronym analgesia and sedative effects of dexmedetomidine and fentanyl on infants scheduled for neurosurgical procedures
Region
Africa

Condition
Condition prospective randomized controlled trail
Classification by specialty
Medicine in general Pediatrics Anesthesiology
Neurosurgery Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluate the efficacyof pain control using perioperative Face, leg agitation, cry and consoability ( FLACC) scores in relating to pain and agitation in infants regarding dexmedetomidine and fentanyl
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the perioperative Face, leg agitation, cry and consoability( FLACC) scores relating to pain and agitation in infants
Key secondary outcomes Changes in hemodynamic both intra and post operatively will supplement our primary outcomes.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1micg/kg dexmedetomedine slowly intravenously and 0.5 mg/kg atracuoruim and intubated with an endotracheal tube of suitable size
Patients will receive Hartman's solution in 5% glucose solution at the ratio 3:1 as by Segar formula. Patients will be ventilated by pressure controlled mode, inspiratory pressure = 20 cmH2O, and rate will be adjusted to maintain end tidal capnography between 30-35 mmHg using Drager medical GmbH, Germany. SN: ASFE - 0040.
Intraoperatively, all patients will have their heart rate, non invasive blood pressure, percentage of oxy haemoglobin and end tidal carbon dioxide as well as body temperature monitored using (Philips 3000 minukeman route, USA SN : US 12572617) and recorded before induction, after endotracheal intubation, every 5 minutes until end of surgery.
Upon finishing surgery sevoflurane will cease and muscle relaxant will be reversed using 0.05 mg/kg neostigmine and 0.01 mg/kg atropine. When the patient regains spontaneous ventilation at adequate rate and depth, the endotracheal tube will be removed and the patient will then be transferred to the recovery area.
In the recovery area, heart rate, non invasive blood pressure, percentage of oxy haemoglobin and F score will be recorded upon arrival and 5, 15, 30 min and upon discharge. If face leg agitation cry and consolability score is 4 or more, patients will receive 7mg/kg of intravenously acetaminophen and reassessed after 5 min.
Interventions/Control_2 fentanyl IV 1micg/kg and 0.5 mg/kg atracuoruim. Anaesthesia will be maintained using sevoflurane in fraction of inspired oxygen 0.3 in air and top up doses of 0.1mg/kg atracorium every 20 min. patients will have Hartman's solution in 5% glucose solution at the ratio 3:1 as by Segar formula.
Patients will be ventilated by pressure controlled mode, inspiratory pressure = 20 cmH2O, and rate will be adjusted to maintain end tidal capnography between 30-35 mmHg using Drager medical GmbH, Germany. SN: ASFE - 0040.
Intraoperatively, all patients will have their heart rate, non invasive blood pressure, percentage of oxy haemoglobin and end tidal carbon dioxide as well as body temperature monitored using (Philips 3000 minukeman route, USA SN : US 12572617) and recorded before induction, after endotracheal intubation, every 5 minutes until end of surgery.
Upon finishing surgery sevoflurane will cease and muscle relaxant will be reversed using 0.05 mg/kg neostigmine and 0.01 mg/kg atropine. When the patient regains spontaneous ventilation at adequate rate and depth, the endotracheal tube will be removed and the patient will then be transferred to the recovery area.
In the recovery area, heart rate, non invasive blood pressure, percentage of oxy haemoglobin and F score will be recorded upon arrival and 5, 15, 30 min and upon discharge. If face leg agitation cry and consolability score is 4 or more, patients will receive 7mg/kg of intravenously acetaminophen and reassessed after 5 min.
The patients will be discharged to the intensive care unit for monitoring of vital signs (heart rate, non-invasive blood pressure, respiration and temperature). Respiratory and circulatory complications will be recorded and handled as appropriate.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 months-old <=
Age-upper limit
24 months-old >=
Gender Male and Female
Key inclusion criteria . It will include patients 2 years old and younger of both gender; after obtaining informed signed consent from patients guardians; who will be schedule for neurosurgical procedures. patients must be older than 44 weeks post gestation
Key exclusion criteria younger than 44 weeks post gestational, with known cardiovascular diseases, renal diseases, hepatic diseases, pulmonary diseases, systemic or local infection will be excluded from this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fatma MF Lahloub
Organization Mansoura university , Faculty of medicine,
Department of anesthesia and surgical intensive care
Division name Neuro anesthesia
Zip code
Address El gomhoreya stree , 35516 mansoura egypt
TEL +201006288357
Email flahloub@mans.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Fatma MF Lahloub
Organization Mansoura university , Faculty of medicine, Department of anesthesia and surgical intensive care
Division name Neuro anesthesia
Zip code
Address El gomhoreya stree , 35516 mansoura egypt
TEL +201006288357
Homepage URL
Email flahloub@mans.edu.eg

Sponsor
Institute Mansoura university , Faculty of medicine, Department of anesthesia and surgical intensive care,Devision of Neuro anesthesia
Institute
Department

Funding Source
Organization self funded
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 01 Day
Last modified on
2015 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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