BradycardiaPhase 4NCT02186132
0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant
A Phase 4 study testing Atropine 0.6 mg and Atropine 1.2 mg in people with Bradycardia and Neostigmine Adverse Reaction, run by Mahidol University.
Trial summary
Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Neostigmine Adverse Reaction, Adverse Reaction to Belladonna or Atropine
- What is being tested?
- Atropine 0.6 mg and Atropine 1.2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3
- age = or > 18 years
- patient receiving neuromuscular blocking agent
Who cannot join
- baseline heart rate before administration of the study drugs < 65 bpm
- history of allergy to the study drugs
- patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
- history of complete heart block or second degree AV block.
About this study
Official title: The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia
Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.
Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)
Read more
Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure.
The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group.
Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy.
The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.
- Being tested
- Atropine 0.6 mg, Atropine 1.2 mg
- Keywords
- heart rate, neostigmine, atropine, dosage
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.6 mgDrug
Atropine 0.6 mg intravenous
Atropine 1.2 mgDrug
Atropine 1.2 mg intravenous
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.6 mg | Experimental | Atropine 0.6 mg intravenous Receives: Drug: Atropine 0.6 mg |
| Atropine 1.2 mg intravenous | Active comparator | Atropine 1.2 mg intravenous Receives: Drug: Atropine 1.2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
Measured: 24 hours
Secondary outcomes (1)
bradycardia
heart rate < 60 beats/min
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- More trials run by Mahidol 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186132
- Sponsor's protocol ID
- Si158/2012
- Status last verified
- Jul 2014
- First submitted
- 7 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia
- ClinicalTrials.gov ID
- NCT02186132
- Acronym / sponsor ID
- Si158/2012
- Keywords
- heart rate, neostigmine, atropine, dosage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jul 2014 (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.
Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.
Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)
Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure.
The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group.
Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy.
The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.
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 |
|---|---|---|
| Atropine 0.6 mg | Experimental | Drug: Atropine 0.6 mgAtropine 0.6 mg intravenous |
| Atropine 1.2 mg intravenous | Active comparator | Drug: Atropine 1.2 mgAtropine 1.2 mg intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status 1-3
- age = or > 18 years
- patient receiving neuromuscular blocking agent
Key exclusion criteria (4 listed)
- baseline heart rate before administration of the study drugs < 65 bpm
- history of allergy to the study drugs
- patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
- history of complete heart block or second degree AV block.
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 |
|---|---|---|
| Atropine 0.6 mgAtropine 0.6 mg intravenous | Drug | Atropine 0.6 mg |
| Atropine 1.2 mgAtropine 1.2 mg intravenous | Drug | Atropine 1.2 mg intravenous |
Primary outcome
heart rate
Time frame: 24 hours
1 secondary outcome
bradycardia
Time frame: 24 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 10 Jul 2014.
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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.
Sirilak Suksompong, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine 0.6 mg and Atropine 1.2 mg in people with Bradycardia and Neostigmine Adverse Reaction, run by Mahidol University.
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 3 inclusion and 4 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
heart rate (time frame: 24 hours). 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 10 Jul 2014.