UMIN-CTR Clinical Trial

Basic information
Public title	low dose intravenous and caudal dexamethasone in caudal anesthesia
Acronym	low dose intravenous and caudal dexamethasone
Scientific Title	Comparison between low dose intravenous and caudal dexamethasone as adjuvants to caudal bupivacaine in children undergoing lower abdominal surgeries
Scientific Title:Acronym	Comparison between low dose intravenous and caudal dexamethasone as adjuvants to caudal bupivacaine in children undergoing lower abdominal surgeries: low dose intravenous and caudal dexamethasone
Region	Africa

Condition
Condition	prospective study
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of low dose dexamethasone intravenous and as adjuvant in caudal anesthesia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	the duration of the postoperative caudal analgesia and severity of postoperative pain
Key secondary outcomes	Number of rescue analgesic doses, residual motor block, and side effects like nausea and vomiting

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	received caudal analgesia with 0.125% bupivacaine 1ml/kg and ten ml normal saline (IV)
Interventions/Control_2	received caudal analgesia with bupivacaine 0.125% 1 ml/kg + 0.1 mg/kg dexamethasone and ten ml normal saline (IV)
Interventions/Control_3	caudal analgesia with 0.125% bupivacaine 1ml/kg and dexamethasone 0.1 mg/ kg in ten ml normal saline(IV)
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	2 years-old <
Age-upper limit	5 years-old >
Gender	Male and Female
Key inclusion criteria	ASA I, II
Key exclusion criteria	coagulopathies, infection at the block targeted site, or with known allergy to any of the drugs included in the study
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Amr Middle name Nady Last name abdelrazik
Organization	Minia University, Faculty of medicine
Division name	anesthesia and intensive care department
Zip code	61768
Address	Minya Elgedida
TEL	00201023451177
Email	m.amr274@yahoo.com

Public contact
Name of contact person	1st name Amr Middle name Nady Last name abdelrazik
Organization	Minya University, Faculty of medicine
Division name	anesthesia and intensive care department
Zip code	61768
Address	Minya Elgedida
TEL	00201023451177
Homepage URL
Email	m.amr274@yahoo.com

Sponsor
Institute	Minia University, Faculty of medicine anesthesia and intensive care department
Institute
Department

Funding Source
Organization	Minia University, Faculty of medicine anesthesia and intensive care department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Egyptian

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

IRB Contact (For public release)
Organization	Minya University
Address	Minya Elgedida
Tel	00862366100
Email	sara.mohamed@mu.edu.eg

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	Minia University, Faculty of medicine anesthesia and intensive care department

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 01 Day

Related information
URL releasing protocol	http://www.editorialmanager.com:10161/pcorm/,
Publication of results	Unpublished

Result
URL related to results and publications	http://www.editorialmanager.com:10161/pcorm/,
Number of participants that the trial has enrolled	150
Results	Dexamethasone promotes the analgesic effect of caudal bupivacaine either if combined with bupivacaine caudally or via (iv) route compared to the control group.
Results date posted	2021 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	There were no statistically significant differences between the study groups including demographic data, ASA classification, type of surgery, and the duration of the surgery
Participant flow	The first analgesic request was significantly prolonged in the caudal dexamethasone group
Adverse events	ide effects reported in the study were PONV, respiratory depression, and shivering. All side effects were comparable in the three groups except nausea and vomiting were significantly fewer in Group IV
Outcome measures	CHIPPS in the postoperative period was comparable between the 3 study groups at the first and third hours, after 6 hours both dexamethasone groups showed lower scores, group D showed significantly lower scores at 24 hours
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2021 Year 04 Month 01 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2021 Year 09 Month 01 Day
Date of closure to data entry	2021 Year 09 Month 01 Day
Date trial data considered complete	2021 Year 09 Month 01 Day
Date analysis concluded	2021 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2021 Year 04 Month 01 Day
Last modified on	2021 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050008