Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

Not Applicable

Completed

• Conditions: Anesthesia, Spinal
• Interventions: Drug: bupivacaine only; Drug: fentanyl

• Registration Number: NCT03105115
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-02
• Study First Posted: 2017-04-07
• Study Start: 2017-05-25
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-26
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine only	bupivacaine only	heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia
intrathecal fentanyl	fentanyl	heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Two segment sensory block regression time	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 Outcome Measures

Name	Time	Method
postoperative pain score	at op day, at postoperative 1st day, at postoperative 2nd day	VAS scale
motor block	From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours	modified Bromage scale
postoperative nausea and vomiting	at op day, at postoperative 1st day, at postoperative 2nd day	VAS scale
intraoperative incidence of hypotension	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of