ED50 of Dexmedetomidine as an Adjuvant to 0.5% Hyperbaric Bupivacaine 12.5 mg for Spinal Anesthesia in Hip and Knee Surgery: An Up-and-Down Method Approach

University of Indonesia (UI)

Status: Completed

Conditions: Spinal Aneshtesia; Knee Surgery; Pelvic Surgery

Treatments: Drug: Dexmedetomidine 5 mcg; Drug: Bupivacain hyperbaric 0.5% 12.5 mg; Drug: Dexmedetomidine 6 mcg; Drug: Dexmedetomidine 3 mcg; Drug: Dexmedetomidine 4 mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT07144215

ED50DEXMEDETOMIDINE

Details and patient eligibility

About

Determine ED50 dexmedetomidine adjuvant that can provide spinal anesthetic sensory blockade duration of 200 minutes on knee and pelvis surgery with up-and-down method.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-60 years old
• Pelvic or knee surgery patient with American Society of Anesthesiologists physical status I - III with epidural spinal anesthesia
• Body mass index 18-35 kg/m2
• Body height 150-180 cm
• Willing to become a research participant

Exclusion criteria

• Have a history of allergy to bupivacaine or dexmedetomidine
• Have sensory or motoric disabilities in the lower extremity contralateral to the surgery area
• Have a history of congestive heart failure and/or heart rhythm disorder
• Have regional anesthesia contraindication

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

Dexmedetomidine 3 mcg

Experimental group

Description:

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 3 mcg.

Treatment:

Drug: Dexmedetomidine 3 mcg

Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 4 mcg

Experimental group

Description:

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 4 mcg.

Treatment:

Drug: Dexmedetomidine 4 mcg

Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 5 mcg

Experimental group

Description:

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 5 mcg.

Treatment:

Drug: Bupivacain hyperbaric 0.5% 12.5 mg

Drug: Dexmedetomidine 5 mcg

Dexmedetomidine 6 mcg

Experimental group

Description:

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg and dexmedetomidine 6 mcg.

Treatment:

Drug: Dexmedetomidine 6 mcg

Drug: Bupivacain hyperbaric 0.5% 12.5 mg