Gastric CancerNCT01857141
Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy
A study testing preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) and normal saline in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Aug 2013
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consented to spinal anesthesia were enrolled
- Patients aged 40~70 years olds undergoing gastrectomy
- No contraindication of epidural analgesia
- ASA class I and II
- Patients consented to epidural anesthesia were enrolled
Who cannot join
- Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias
- patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
Seoul, Seoul, 120-752
About this study
The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.
- Conditions
- Gastric Cancer
- Being tested
- preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg), normal saline
- Keywords
- dexmedetomidine, heart rate variability, preemptive epidural, gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)Drug
Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of
normal salineDrug
patients in the control groups received the equivalent volume of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Not described Receives: Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability analysis
Heart rate variability analysis was performed according to the Task Force recommendations.
Frequency domain analysis was based on fast Fourier transformation. Power spectrum densities were calculated for low frequencies (LF: 0.04-0.15 Hz) and high frequencies (HF: 0.15-0.4 Hz) informalized units, defined as the LF or HF proportional part of the total power.
Baseline and 30min after the injection of the study drug.
Measured: 5min perioids after fluid resuscitation.
Secondary outcomes (1)
Epidural injection
And secondary data collection was done at 30 min after the epidural injection of the study drug.
All of the HRV analysis was done before anaesthesia induction.
Measured: at 30 min after the epidural injection of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857141
- Sponsor's protocol ID
- 4-2011-0904
- Status last verified
- Feb 2014
- First submitted
- 12 May 2013
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bajwa SJ, Bajwa SK, Kaur J, Singh G, Arora V, Gupta S, Kulshrestha A, Singh A, Parmar S, Singh A, Goraya S. Dexmedetomidine and clonidine in epidural anaesthesia: A comparative evaluation. Indian J Anaesth. 2011 Mar;55(2):116-21. doi: 10.4103/0019-5049.79883.
PubMed 21712865Chatzimichali A, Zoumprouli A, Metaxari M, Apostolakis I, Daras T, Tzanakis N, Askitopoulou H. Heart rate variability may identify patients who will develop severe bradycardia during spinal anaesthesia. Acta Anaesthesiol Scand. 2011 Feb;55(2):234-41. doi: 10.1111/j.1399-6576.2010.02339.x. Epub 2010 Nov 8.
PubMed 21058941Hanss R, Bein B, Weseloh H, Bauer M, Cavus E, Steinfath M, Scholz J, Tonner PH. Heart rate variability predicts severe hypotension after spinal anesthesia. Anesthesiology. 2006 Mar;104(3):537-45. doi: 10.1097/00000542-200603000-00022.
PubMed 16508402Penttila J, Helminen A, Anttila M, Hinkka S, Scheinin H. Cardiovascular and parasympathetic effects of dexmedetomidine in healthy subjects. Can J Physiol Pharmacol. 2004 May;82(5):359-62. doi: 10.1139/y04-028.
PubMed 15213737Schnaider TB, Vieira AM, Brandao AC, Lobo MV. [Intraoperative analgesic effect of epidural ketamine, clonidine or dexmedetomidine for upper abdominal surgery.]. Rev Bras Anestesiol. 2005 Oct;55(5):525-31. doi: 10.1590/s0034-70942005000500007. Portuguese.
PubMed 19468643
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy
- ClinicalTrials.gov ID
- NCT01857141
- Acronym / sponsor ID
- 4-2011-0904
- Conditions
- Gastric Cancer
- Keywords
- dexmedetomidine, heart rate variability, preemptive epidural, gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 May 2013 (estimated)
- 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.
The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) |
| normal saline | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients consented to spinal anesthesia were enrolled
- Patients aged 40~70 years olds undergoing gastrectomy
- No contraindication of epidural analgesia
- ASA class I and II
- Patients consented to epidural anesthesia were enrolled
Key exclusion criteria (2 listed)
- Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias
- patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study
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 |
|---|---|---|
| preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of | Drug | dexmedetomidine |
| normal salinepatients in the control groups received the equivalent volume of normal saline. | Drug | normal saline |
Primary outcome
Heart rate variability analysis
Time frame: 5min perioids after fluid resuscitation.
Heart rate variability analysis was performed according to the Task Force recommendations. Frequency domain analysis was based on fast Fourier transformation. Power spectrum densities were calculated for low frequencies (LF: 0.04-0.15 Hz) and high frequencies (HF: 0.15-0.4 Hz) informalized units, defined as the LF or HF proportional part of the total power. Baseline and 30min after the injection of the study drug.
1 secondary outcome
Epidural injection
Time frame: at 30 min after the epidural injection of the study drug
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 5 Feb 2014.
- Background: PubMed 21712865Bajwa SJ, Bajwa SK, Kaur J, Singh G, Arora V, Gupta S, Kulshrestha A, Singh A, Parmar S, Singh A, Goraya S. Dexmedetomidine and clonidine in epidural anaesthesia: A comparative evaluation. Indian J Anaesth. 2011 Mar;55(2):116-21. doi: 10.4103/0019-5049.79883.
- Background: PubMed 21058941Chatzimichali A, Zoumprouli A, Metaxari M, Apostolakis I, Daras T, Tzanakis N, Askitopoulou H. Heart rate variability may identify patients who will develop severe bradycardia during spinal anaesthesia. Acta Anaesthesiol Scand. 2011 Feb;55(2):234-41. doi: 10.1111/j.1399-6576.2010.02339.x. Epub 2010 Nov 8.
- Background: PubMed 16508402Hanss R, Bein B, Weseloh H, Bauer M, Cavus E, Steinfath M, Scholz J, Tonner PH. Heart rate variability predicts severe hypotension after spinal anesthesia. Anesthesiology. 2006 Mar;104(3):537-45. doi: 10.1097/00000542-200603000-00022.
- Background: PubMed 15213737Penttila J, Helminen A, Anttila M, Hinkka S, Scheinin H. Cardiovascular and parasympathetic effects of dexmedetomidine in healthy subjects. Can J Physiol Pharmacol. 2004 May;82(5):359-62. doi: 10.1139/y04-028.
- Background: PubMed 19468643Schnaider TB, Vieira AM, Brandao AC, Lobo MV. [Intraoperative analgesic effect of epidural ketamine, clonidine or dexmedetomidine for upper abdominal surgery.]. Rev Bras Anestesiol. 2005 Oct;55(5):525-31. doi: 10.1590/s0034-70942005000500007. Portuguese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) and normal saline in people with Gastric Cancer, run by Yonsei University 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 5 inclusion and 2 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 5 Feb 2014. 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. Some participants in this study may receive a placebo. 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?
Heart rate variability analysis (time frame: 5min perioids after fluid resuscitation.). 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 NCT01857141, which also lists 5 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 5 Feb 2014.