Spinal AnesthesiaNCT03322150
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
A study testing Atropine and Glycopyrrolate in people with Spinal Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Atropine and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2017to 1 Aug 2018
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
- ASA class 1-3
Who cannot join
- Patients with coagulation abnormalities
- End organ diseases of liver, lung or kidney
- Severe aortic stenosis
- High degree AV block
- Heart failure
- Patients on MAO inhibitors
- History of seizures or epilepsy
- Glaucoma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.
- Conditions
- Spinal Anesthesia
- Being tested
- Atropine, Glycopyrrolate
- Keywords
- Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Atropine injection (0.01 mg/kg, max 0.5 mg) 3 minutes before spinal anesthesia
GlycopyrrolateDrug
Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Atropine group | Active comparator | Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia Receives: Drug: Atropine |
| Glycopyrrolate group | Active comparator | Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia Receives: Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate
measured as beats per minute, heart rate below 60 bpm or decrease of more than 30% from baseline is defined as bradycardia.
Measured: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
blood pressure
measured as mmHg, mean blood pressure lower than 60 mmHg or decrease of more than 30% from baseline is defined as hypotension.
Measured: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 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
- NCT03322150
- Sponsor's protocol ID
- 4-2013-0763
- Status last verified
- Mar 2019
- First submitted
- 23 Oct 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03322150
- Acronym / sponsor ID
- 4-2013-0763
- Conditions
- Spinal Anesthesia
- Keywords
- Atropine, glycopyrrolate, bradycardia, dexmedetomidine, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 26 Oct 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.
Patients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine group | Active comparator | Drug: AtropinePatients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia |
| Glycopyrrolate group | Active comparator | Drug: GlycopyrrolatePatients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
- ASA class 1-3
Key exclusion criteria (8 listed)
- Patients with coagulation abnormalities
- End organ diseases of liver, lung or kidney
- Severe aortic stenosis
- High degree AV block
- Heart failure
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 |
|---|---|---|
| AtropineAtropine injection (0.01 mg/kg, max 0.5 mg) 3 minutes before spinal anesthesia | Drug | Atropine group |
| GlycopyrrolateGlycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia | Drug | Glycopyrrolate group |
Primary outcome
Pulse rate
Time frame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
measured as beats per minute, heart rate below 60 bpm or decrease of more than 30% from baseline is defined as bradycardia.
blood pressure
Time frame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)
measured as mmHg, mean blood pressure lower than 60 mmHg or decrease of more than 30% from baseline is defined as hypotension.
Results and safety
The study was stopped early (reason given: The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- 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.
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 Atropine and Glycopyrrolate in people with Spinal Anesthesia, 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Mar 2019. 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 was stopped early (reason given: The research was terminated because the recruitment of the study subjects was not smooth and the overseas training of the investigator was scheduled.). Results are not available in the source record.
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?
Pulse rate (time frame: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)). The study lists 2 primary outcomes in all. 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 14 Mar 2019.