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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Surgery Pelvic Surgery Spinal Aneshtesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dexmedetomidine 3 mcg

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

Group Type EXPERIMENTAL

Dexmedetomidine 3 mcg

Intervention Type DRUG

Patient received spinal injection of dexmedetomidine 3 mcg.

Bupivacain hyperbaric 0.5% 12.5 mg

Intervention Type DRUG

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 4 mcg

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

Group Type EXPERIMENTAL

Dexmedetomidine 4 mcg

Intervention Type DRUG

Patient received spinal injection of dexmedetomidine 4 mcg.

Bupivacain hyperbaric 0.5% 12.5 mg

Intervention Type DRUG

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 5 mcg

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

Group Type EXPERIMENTAL

Dexmedetomidine 5 mcg

Intervention Type DRUG

Patient received spinal injection of dexmedetomidine 5 mcg.

Bupivacain hyperbaric 0.5% 12.5 mg

Intervention Type DRUG

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Dexmedetomidine 6 mcg

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

Group Type EXPERIMENTAL

Dexmedetomidine 6 mcg

Intervention Type DRUG

Patient received spinal injection of dexmedetomidine 6 mcg.

Bupivacain hyperbaric 0.5% 12.5 mg

Intervention Type DRUG

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Interventions

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Dexmedetomidine 3 mcg

Patient received spinal injection of dexmedetomidine 3 mcg.

Intervention Type DRUG

Dexmedetomidine 4 mcg

Patient received spinal injection of dexmedetomidine 4 mcg.

Intervention Type DRUG

Dexmedetomidine 5 mcg

Patient received spinal injection of dexmedetomidine 5 mcg.

Intervention Type DRUG

Dexmedetomidine 6 mcg

Patient received spinal injection of dexmedetomidine 6 mcg.

Intervention Type DRUG

Bupivacain hyperbaric 0.5% 12.5 mg

Patient received spinal injection of Bupivacain hyperbaric 0.5% 12.5 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes