Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Spinal
• Intervention / Treatment: Drug: fentanyl; Drug: bupivacaine only

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intrathecal fentanyl; heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia	Drug: fentanyl; 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
Experimental: bupivacaine only; heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia	Drug: bupivacaine only; heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation; Other Names: AstraZeneca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two segment sensory block regression time	Time from highest sensory block level to two segment regression	From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
motor block	modified Bromage scale	From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
postoperative pain score	VAS scale	at op day, at postoperative 1st day, at postoperative 2nd day
postoperative nausea and vomiting	VAS scale	at op day, at postoperative 1st day, at postoperative 2nd day
intraoperative incidence of hypotension	hypotension : SBP decreased by more than 30% of baseline SBP	From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Seetharam KR, Bhat G. Effects of isobaric ropivacaine with or without fentanyl in subarachnoid blockade: A prospective double-blind, randomized study. Anesth Essays Res. 2015 May-Aug;9(2):173-7. doi: 10.4103/0259-1162.152149.
• Singh R, Kundra S, Gupta S, Grewal A, Tewari A. Effect of clonidine and/or fentanyl in combination with intrathecal bupivacaine for lower limb surgery. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):485-90. doi: 10.4103/0970-9185.169069.
• Park SK, Lee JH, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Comparison of bupivacaine plus intrathecal fentanyl and bupivacaine alone for spinal anesthesia with intravenous dexmedetomidine sedation: a randomized, double-blind, noninferiority trial. Reg Anesth Pain Med. 2019 Apr;44(4):459-465. doi: 10.1136/rapm-2018-100084. Epub 2019 Jan 23.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): October 24, 2017
• Study Completion (Actual): October 26, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 2, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: dexmedetomidine; fentanyl
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: H-1612-099-815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No