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OpenTrials
Completed

NCT Number: NCT03105115

Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

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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Key information

Conditions

Anesthesia, Spinal

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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

Other names: Hana Pharmacy

Bupivacaine Only

Drug

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

Other names: AstraZeneca

Primary outcomes

  1. Two segment sensory block regression time

    Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

    Time from highest sensory block level to two segment regression

Secondary outcomes

  1. motor block

    Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

    modified Bromage scale

  2. postoperative pain score

    Time frame: at op day, at postoperative 1st day, at postoperative 2nd day

    VAS scale

  3. postoperative nausea and vomiting

    Time frame: at op day, at postoperative 1st day, at postoperative 2nd day

    VAS scale

  4. intraoperative incidence of hypotension

    Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

    hypotension : SBP decreased by more than 30% of baseline SBP

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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