UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy
Acronym	Comparison of intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy
Scientific Title	Comparison of intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy
Scientific Title:Acronym	Comparison of intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy
Region	Asia(except Japan)

Condition
Condition	Intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare intrathecal fentanyl and midazolam in combination with hyperbaric bupivacaine, for the duration and quality of sensory and motor blockade after spinal anesthesia in patients undergoing appendicectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intrathecal midazolam and fentanyl added to bupivacaine in patients undergoing appendicectomy reduces intraoperative pain and increases duration of post-operative analgesia.
Key secondary outcomes

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	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Group BM: Intrathecal 3ml of 0.5% hyperbaric Bupivacaine with 0.4ml (2mg) midazolam
Interventions/Control_2	Group BF: Intrathecal 3ml 0.5% hyperbaric Bupivacaine with 0.4mls (20micrograms) Fentanyl
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	15 years-old <
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Scheduled for elective or emergency appendicectomy requiring sub arachnoid block. 2) All patients of ASA physical status I-II. 3) Age group of 15-70 yrs of age.
Key exclusion criteria	1) Patient refusal. 2) Infection at the site of injection. 3) Deformities of spinal column. 4) Mental disturbance or neurological disease. 5) Known case of allergic to drugs used.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Puja Middle name Last name Thapa
Organization	Nepal Army Institute of Health Sciences
Division name	Bagmati
Zip code	44600
Address	Chhauni,Kathmandu
TEL	+9779851152449
Email	thapa_puza@yahoo.com

Public contact
Name of contact person	1st name Puja Middle name Last name Thapa
Organization	Nepalese Army Institute of Health Sciences
Division name	Bagmati
Zip code	44600
Address	Chhauni, Kathmandu
TEL	+9779851152449
Homepage URL	http://naihs.edu.np/
Email	thapa_puza@yahoo.com

Sponsor
Institute	Shree Birendra Hospital
Institute
Department

Funding Source
Organization	Nepal Army Institute of Health Sciences
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nepalese Army Institute of Health Sciences
Address	Sanobharyang, kathmandu
Tel	+977-1-4881259
Email	info@naihs.edu.np

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	2021 Year 01 Month 23 Day

Related information
URL releasing protocol	https://www.nepjol.info/index.php/nmj/authorDashboard/submission/34398
Publication of results	Unpublished

Result
URL related to results and publications	https://www.nepjol.info/index.php/nmj/authorDashboard/submission/34398
Number of participants that the trial has enrolled	50
Results	Total 44 patients were studied with 22 in each arm. The two groups were comparable in terms of age, weight, height, duration of surgery and ASA status of the patients. Peak sensory level and degree of motor block were not statistically different in two arms. Duration of effective analgesia was 293.16 min in BF group and 267.80 min in BM group. Increased incidence of pruritus was recorded during the postoperative period in Fentanyl group.
Results date posted	2021 Year 01 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	They were similar in baseline characteristics
Participant flow	Out of the 50 cases, 44 patients were enrolled in the study with 22 in each arm.
Adverse events	None except minor cases of pruritus
Outcome measures	There was no statistical difference in peak sensory level, degree of motor block and quality of intraoperative analgesia between two groups
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 14 Day
Date of IRB	2018 Year 06 Month 24 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 23 Day
Last modified on	2021 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043410

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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