UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058861 |
|---|---|
| Receipt number | R000067289 |
| Scientific Title | The Effect of Intravenous Dexmedetomidine on the Duration of Spinal Block and Postoperative Pain in Women Undergoing Cesarean Section |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/22 07:28:18 |
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Basic information
Public title
The Effect of Intravenous Dexmedetomidine on the Duration of Spinal Block and Postoperative Pain in Women Undergoing Cesarean Section
Acronym
Dex-Ces
Scientific Title
The Effect of Intravenous Dexmedetomidine on the Duration of Spinal Block and Postoperative Pain in Women Undergoing Cesarean Section
Scientific Title:Acronym
Dex-Ces
Region
| Asia(except Japan) |
Condition
Condition
it is thesis of pharmacy student that was done at the university hospital
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Anesthesiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate whether an intravenous bolus of dexmedetomidine given with spinal anesthesia prolongs sensory and motor block duration, shortens sensory block onset, reduces postoperative pain up to 24 hours, and affects peri-/post-operative adverse events in women undergoing non-emergency cesarean section.Postoperative pain intensity measured by Visual Analog Scale (0-10) at 2, 6, 12, and 24 hours after cesarean section
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative pain intensity measured by Visual Analog Scale (VAS) scores at 2, 6, 12, and 24 hours after cesarean section.
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Participants were randomized into two groups using a computer generated sequence:
Dexmedetomidine group (n=25): Received 12.5 mg of 0.5% hyperbaric bupivacaine intrathecally and an intravenous bolus of dexmedetomidine (0.2 mcg/kg) over 10 minutes after delivery.
Interventions/Control_2
Control group (n=25): Received 12.5 mg of 0.5% hyperbaric bupivacaine intrathecally and an intravenous bolus of normal saline (0.2 mcg/kg).
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
American Society of Anesthesiologists physical status 1 and 2. Age 18-40 years. Full term pregnancy (37-40 weeks).
Key exclusion criteria
History of adverse reactions to local anesthetics or dexmedetomidine. Contraindications to spinal anesthesia. Emergency cesarean sections.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seyed |
| Middle name | Mojtaba |
| Last name | Sohrevardi |
Organization
Faculty of Pharmacy, Shahid Sadoughi University of Med. Sciences
Division name
Pharmacotherapy department
Zip code
8916978477
Address
School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
TEL
+989134512422
smsohrevardi@yahoo.com
Public contact
Name of contact person
| 1st name | seyed |
| Middle name | Mojtaba |
| Last name | sohrevardi |
Organization
faculty of Pharmacy
Division name
pharmacotherapy department
Zip code
8916978477
Address
School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq
TEL
+989134512422
Homepage URL
https://en.ssu.ac.ir/pharm/about/
smsohrevardi@yahoo.com
Sponsor or person
Institute
School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Institute
Department
Personal name
Funding Source
Organization
Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Iran
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Address
School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
Tel
+983538203410
international@ssu.ac.ir
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
| 2025 | Year | 08 | Month | 22 | 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
50
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067289
