Clinical trial
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Name
AP210330102
Description
Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries
Trial arms
Trial start
2021-03-15
Estimated PCD
2022-03-10
Trial end
2022-03-10
Status
Completed
Phase
Early phase I
Treatment
Dexmedetomidine
5 micrograms intrathecal dexmedetomidine
Arms:
Heavy Bupivacaine plus dexmedetomidine
Other names:
Spinal dexmedetomidine
Midazolam
2 milligrams intrathecal midazolam
Arms:
Heavy Bupivacaine plus midazolam
Other names:
Spinal midazolam
Bupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine
Arms:
Heavy Bupivacaine plus dexmedetomidine, Heavy Bupivacaine plus midazolam, Heavy Bupivacaine plus normal saline
Other names:
Spinal bupivacaine
Size
75
Primary endpoint
Duration of sensory block
12 hours
Eligibility criteria
Inclusion Criteria:
* Patients undergoing lower limb orthopedic cancer surgery.
* ASA I, II, III.
* Age 20 to 70 year
* Healthy volunteers
Exclusion Criteria:
* Age less than 20 and older than 70.
* ASA IV, V.
* patients' refusal.
* patients with coagulopathy.
* patients with severe valvular stenosis
* patients with infection at site of injection
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}
Updated at
2024-03-18
1 organization
3 products
1 indication
Organization
National Cancer Institute, EgyptProduct
DexmedetomidineIndication
Postoperative PainProduct
MidazolamProduct
Bupivacain