Intrathecal Dexmedetomidine vs Midazolame

National Cancer Institute, Egypt

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT06315634

AP210330102

Details and patient eligibility

About

Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries

Full description

Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients

Enrollment: 75 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Heavy Bupivacaine plus normal saline

Active Comparator group

Description:

2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline

Treatment:

Drug: Bupivacain

Heavy Bupivacaine plus dexmedetomidine

Experimental group

Description:

2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline

Treatment:

Drug: Bupivacain

Drug: Dexmedetomidine

Heavy Bupivacaine plus midazolam

Experimental group

Description:

2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline

Treatment:

Drug: Bupivacain

Drug: Midazolam