BradycardiaPhase 4NCT02522858
Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia
A Phase 4 study testing Atropine, Dexmedetomidine and Ephedrine in people with Bradycardia, run by Sira Bang at 1 site in South Korea.
Trial summary
Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Atropine, Dexmedetomidine and Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Jan 2016
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergoing spinal anesthesia with sedation over 19 years old.
Who cannot join
- Patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs.
- Patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Seoul Paik Hospital, Seoul, Korea
Seoul, Jung-Gu,, 100-032
About this study
Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.
Read the detailed description
Before entering the operation room, patients are randomized in one group (A or C). For sedative premedication, all patients will be injected intramuscularly with midazolam 1mg. After entering the operation room, all patients will be monitored blood pressure, ECG and oxygen saturation. Before induction of spinal anesthesia, all patients will be loaded with plasma solution 5mL/kg. After induction of spinal anesthesia, block level will be checked. After fixation of block level, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes. However, just before starting dexmedetomidine,atropine .01~0.03mg/kg up to 0.5mg would be injected in group A. Otherwise normal saline 0.5mL would be injected in group C. The syringed would be blinding not to be noticed. After loading of dexmedetomidine, the diluted solution would be injected with 0.25ug/kg/hr until the end of the surgery. Every patients undergoing sedation would be applied the oxygen by nasal prong.
The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. The number of medication treated would be noted.
- Conditions
- Bradycardia
- Being tested
- Atropine, Dexmedetomidine, Ephedrine
- Keywords
- premedication, dexmedetomidine, anesthesia, spinal
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
To evaluate the effectiveness of atropine on prevention bradycardia,atropine 0.01~0.03mg/kg up to 0.5mg would be injected intravenously just before starting loading dose of dexmedetomidine in group A.
During operation, heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. This intervention would be applied to both group.
DexmedetomidineDrug
Dexmedetomidine is a highly selective a2 adrenergic receptor antagonist used as sedative agent. After confirming the fixation level of spinal anesthesia, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes.Maintenance dose(0.25ug/kg/hr) would be continued after loading dose.
EphedrineDrug
Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, normal saline 0.5mL would be injected intravenously. Receives: Drug: Dexmedetomidine; Drug: Ephedrine |
| Atropine | Experimental | After fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously. Receives: Drug: Atropine; Drug: Dexmedetomidine; Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of bradycardia
The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously.
Measured: 30miniutes from starting dexmedetomidine with loading dose
Secondary outcomes (1)
The incidence of hypotension
Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously.
Measured: 30miniutes from starting dexmedetomidine with loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sira Bang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sira Bang, Inje University
- Investigators
- Sira Bang, MD PhD, Principal investigator, Inje University Seoul Paik Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522858
- Sponsor's protocol ID
- IIT-2015-101
- Status last verified
- Jan 2016
- First submitted
- 5 Aug 2015
- Last updated
- 18 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02522858
- Acronym / sponsor ID
- IIT-2015-101
- Conditions
- Bradycardia
- Keywords
- premedication, dexmedetomidine, anesthesia, spinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sira BangUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Aug 2015 (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.
Dexmedetomidine is a selective α2 adrenergic receptor antagonist, which has little effect on respiratory suppression used as sedative agent. Also, dexmedetomidine has been reported to prolong the anesthesia time when used with patients undergoing spinal anesthesia. However, dexmedetomidine has sympathetic effect which can cause hypotension and bradycardia dose dependently. Therefore, this study is aimed to evaluate the effectiveness of premedication of anticholinergic agents on vital sign in patients undergoing spinal anesthesia.
Detailed description
Before entering the operation room, patients are randomized in one group (A or C). For sedative premedication, all patients will be injected intramuscularly with midazolam 1mg. After entering the operation room, all patients will be monitored blood pressure, ECG and oxygen saturation. Before induction of spinal anesthesia, all patients will be loaded with plasma solution 5mL/kg. After induction of spinal anesthesia, block level will be checked. After fixation of block level, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes. However, just before starting dexmedetomidine,atropine .01~0.03mg/kg up to 0.5mg would be injected in group A. Otherwise normal saline 0.5mL would be injected in group C. The syringed would be blinding not to be noticed. After loading of dexmedetomidine, the diluted solution would be injected with 0.25ug/kg/hr until the end of the surgery. Every patients undergoing sedation would be applied the oxygen by nasal prong.
The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. The number of medication treated would be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Dexmedetomidine, Drug: EphedrineAfter fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, normal saline 0.5mL would be injected intravenously. |
| Atropine | Experimental | Drug: Atropine, Drug: Dexmedetomidine, Drug: EphedrineAfter fixation of the block level of spinal anesthesia, and just before starting dexmedetomidine, ,atropine 0.03mg/kg would be injected intravenously. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergoing spinal anesthesia with sedation over 19 years old.
Key exclusion criteria (2 listed)
- Patients who are contraindicated of spinal anesthesia such as hypovolemic status, coagulation disorder, infection of tapping site, pregnancy, heart problem, history of drug allergy, drug abuser, anemia, headache and medication of antipsychotic drugs.
- Patiensts who are contraindicated of atropine such as glaucoma, voiding difficulty due to prostate hyperplasia, heart disease, ulcerative colitis, hyperthyroidism and fever.
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 |
|---|---|---|
| AtropineTo evaluate the effectiveness of atropine on prevention bradycardia,atropine 0.01~0.03mg/kg up to 0.5mg would be injected intravenously just before starting loading dose of dexmedetomidine in group A. During operation, heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. This intervention would be applied to both group. | Drug | Atropine |
| DexmedetomidineDexmedetomidine is a highly selective a2 adrenergic receptor antagonist used as sedative agent. After confirming the fixation level of spinal anesthesia, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes.Maintenance dose(0.25ug/kg/hr) would be continued after loading dose. | Drug | Atropine, Placebo |
| EphedrineSystolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously. | Drug | Atropine, Placebo |
Primary outcome
The incidence of bradycardia
Time frame: 30miniutes from starting dexmedetomidine with loading dose
The heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously.
1 secondary outcome
The incidence of hypotension
Time frame: 30miniutes from starting dexmedetomidine with loading dose
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 18 Jan 2016.
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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.
Sira Bang, MD PhD principal investigator
Inje University Seoul Paik Hospital, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine, Dexmedetomidine and Ephedrine in people with Bradycardia, run by Sira Bang 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 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 18 Jan 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of bradycardia (time frame: 30miniutes from starting dexmedetomidine with loading dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2016.