Anesthesia, SpinalNCT03105115
Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion
A study testing fentanyl and bupivacaine only in people with Anesthesia, Spinal, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- fentanyl and bupivacaine only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2017to 26 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Spinal
- Being tested
- fentanyl, bupivacaine only
- Keywords
- fentanyl, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Also called Hana Pharmacy
intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation
bupivacaine onlyDrug
Also called AstraZeneca
heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation
| Study group | Role | What they receive |
|---|---|---|
| intrathecal fentanyl | Active comparator | heavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia Receives: Drug: fentanyl |
| bupivacaine only | Experimental | heavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia Receives: Drug: bupivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two segment sensory block regression time
Time from highest sensory block level to two segment regression
Measured: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Secondary outcomes (4)
motor block
modified Bromage scale
Measured: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
postoperative pain score
VAS scale
Measured: at op day, at postoperative 1st day, at postoperative 2nd day
postoperative nausea and vomiting
VAS scale
Measured: 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
Measured: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start25 May 2017
- Primary completion24 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-tae Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105115
- Sponsor's protocol ID
- H-1612-099-815
- Status last verified
- Aug 2018
- First submitted
- 30 Mar 2017
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26417123Singh 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.
PubMed 26702205Park 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.
PubMed 30679336
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine
- ClinicalTrials.gov ID
- NCT03105115
- Acronym / sponsor ID
- H-1612-099-815
- Conditions
- Anesthesia, Spinal
- Keywords
- fentanyl, dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal fentanyl | Active comparator | Drug: fentanylheavy bupivacaine 14mg and fentanyl 20mcg will be injected intrathecally during spinal anesthesia |
| bupivacaine only | Experimental | Drug: bupivacaine onlyheavy bupivacaine 14mg will be injected intrathecally during spinal anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia
Key exclusion criteria (7 listed)
- Contraindication of spinal anesthesia
- inability to communicate
- morbid obesity (BMI > 30kg/m2)
- spine abnormality
- severe cardiac dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanylAlso: Hana Pharmacyintrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation | Drug | intrathecal fentanyl |
| bupivacaine onlyAlso: AstraZenecaheavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation | Drug | bupivacaine only |
Primary outcome
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
4 secondary outcomes
motor block
Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
postoperative pain score
Time frame: at op day, at postoperative 1st day, at postoperative 2nd day
postoperative nausea and vomiting
Time frame: at op day, at postoperative 1st day, at postoperative 2nd day
intraoperative incidence of hypotension
Time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 26417123Seetharam 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.
- Background: PubMed 26702205Singh 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.
- Derived from this study: PubMed 30679336Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-tae Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fentanyl and bupivacaine only in people with Anesthesia, Spinal, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two segment sensory block regression time (time frame: From completion of spinal anesthesia, to end of surgery, an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105115, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.