UMIN-CTR Clinical Trial

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

prospective randomized controlled trail

Classification by specialty

Medicine in general	Pediatrics	Anesthesiology
Neurosurgery	Child

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

self funded

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

12

Month

01

Day

Last modified on

2015

Year

12

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023106