Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-25

Study Completion Date

2017-10-26

Brief Summary

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Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had additional prolonging effect on duration of spinal anesthesia or not. Therefore, the investigators planned this trial to compare clinical outcomes in patients receiving spinal anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.

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Detailed Description

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Conditions

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Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intrathecal fentanyl

heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation

bupivacaine only

heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia

Group Type EXPERIMENTAL

bupivacaine only

Intervention Type DRUG

heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation

Interventions

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fentanyl

intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation

Intervention Type DRUG

bupivacaine only

heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation

Intervention Type DRUG

Other Intervention Names

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Hana Pharmacy AstraZeneca

Eligibility Criteria

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Inclusion Criteria

* Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia

Exclusion Criteria

* Contraindication of spinal anesthesia
* inability to communicate
* morbid obesity (BMI \> 30kg/m2)
* spine abnormality
* severe cardiac dysfunction
* Height \<155cm, or \> 180cm
* contraindication to fentanyl

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No