Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

Seoul National University

Status: Completed

Conditions: Anesthesia, Spinal

Treatments: Drug: fentanyl; Drug: bupivacaine only

Study type: Interventional

Funder types: Other

Identifiers

NCT03105115

H-1612-099-815

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

intrathecal fentanyl

Active Comparator group

Description:

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

Treatment:

Drug: fentanyl

bupivacaine only

Experimental group

Description:

heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia

Treatment:

Drug: bupivacaine only