UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043105 |
|---|---|
| Receipt number | R000043410 |
| Scientific Title | Comparison of intrathecal midazolam and fentanyl added to bupivacaine for spinal anesthesia in patients undergoing appendicectomy |
| Date of disclosure of the study information | 2021/01/23 |
| Last modified on | 2021/01/23 02:47:01 |
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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
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/
thapa_puza@yahoo.com
Sponsor or person
Institute
Shree Birendra Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043410
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