BradyarrhythmiaNCT05997004
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
A study testing Normal Saline and Glycopyrrolate in people with Bradyarrhythmia and Cardiac Arrest, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
Trial summary
The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question[s] it aims to answer are: Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery? If the patient get Glycopyrrolate, Does it really prevent… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Bradyarrhythmia, Cardiac Arrest, Tachycardia
- What is being tested?
- Normal Saline and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNepal
- Study dates
- 1 May 2018to 15 Nov 2019
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients of either sex aged 15-65 years
- Patient undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I
Who cannot join
- Patients with history of recent or past cardiac diseases
- Patients with pre-operative heart rate ≤60beats/min.
- Patients on cardiac medications
- Allergic to Glycopyrrolate
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question[s] it aims to answer are:
- Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?
- If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?
Read the detailed description
The emergence of laparoscopic surgery has changed the way of approach for several organs. Despite several advantages, laparoscopic surgery may result in serious complications due to the physiologic changes which occur during the procedure. The cardiovascular system is one of the most challenged systems of the human body during laparoscopy. The insufflation of gas into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal insufflation. There are studies addressing measures to prevent or control cardiovascular catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during Laparoscopic Cholecystectomy.
General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia during Laparoscopic cholecystectomy.
Specific objective
- To evaluate the change in heart rate and rhythm at different time interval after pneumoperitoneum.
- To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at different time interval after pneumoperitoneum.
- Conditions
- Bradyarrhythmia, Cardiac Arrest, Tachycardia, Asystole
- Being tested
- Normal Saline, Glycopyrrolate
- Keywords
- Glycopyrrolate, Bradyarrhythmia, Laparoscopy, Pneumoperitoneum, Cardiac Arrest
- Medical subject headings
- Bradycardia, Heart Arrest, Tachycardia, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
After surgical creation of umbilical port Control group received injection normal saline 1ml.
GlycopyrrolateDrug
After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 31 participants received 1ml of Normal Saline Receives: Drug: Normal Saline |
| Glyco | Experimental | 31 participants received 1ml (0.2mg) of Glycopyrrolate Receives: Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (Bradycardia)
The primary outcome will be Bradycardia defined as heart rate below 60beats per minute
Measured: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Secondary outcomes (3)
Systolic Blood Pressure
Monitoring of systolic Blood pressure
Measured: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Diastolic Blood Pressure
Monitoring of diastolic Blood pressure
Measured: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Mean Arterial Pressure
Monitoring of Mean Arteria pressure
Measured: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 May 2018
- Primary completion20 May 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Academy of Medical Sciences, Nepal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Brihaspati K C, National Academy of Medical Sciences, Nepal
- Investigators
- Brihaspati K C, MD, Principal investigator, NAMS Bir HospitalBrahmadev Jha, MD, Study chair, NAMS Bir HospitalSurendra Bhusal, MD, Study chair, NAMS Bir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997004
- Sponsor's protocol ID
- NAMS Nepal
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05997004
- Acronym / sponsor ID
- NAMS Nepal
- Conditions
- Bradyarrhythmia, Cardiac Arrest, Tachycardia, Asystole
- Keywords
- Glycopyrrolate, Bradyarrhythmia, Laparoscopy, Pneumoperitoneum, Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Academy of Medical Sciences, NepalOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 18 Aug 2023 (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.
The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question[s] it aims to answer are:
- Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?
- If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?
Detailed description
The emergence of laparoscopic surgery has changed the way of approach for several organs. Despite several advantages, laparoscopic surgery may result in serious complications due to the physiologic changes which occur during the procedure. The cardiovascular system is one of the most challenged systems of the human body during laparoscopy. The insufflation of gas into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal insufflation. There are studies addressing measures to prevent or control cardiovascular catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during Laparoscopic Cholecystectomy.
General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia during Laparoscopic cholecystectomy.
Specific objective
- To evaluate the change in heart rate and rhythm at different time interval after pneumoperitoneum.
- To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at different time interval after pneumoperitoneum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal Saline31 participants received 1ml of Normal Saline |
| Glyco | Experimental | Drug: Glycopyrrolate31 participants received 1ml (0.2mg) of Glycopyrrolate |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients of either sex aged 15-65 years
- Patient undergoing elective laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) physical status I
Key exclusion criteria (4 listed)
- Patients with history of recent or past cardiac diseases
- Patients with pre-operative heart rate ≤60beats/min.
- Patients on cardiac medications
- Allergic to Glycopyrrolate
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 |
|---|---|---|
| Normal SalineAfter surgical creation of umbilical port Control group received injection normal saline 1ml. | Drug | Control |
| GlycopyrrolateAfter surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg | Drug | Glyco |
Primary outcome
Heart Rate (Bradycardia)
Time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
The primary outcome will be Bradycardia defined as heart rate below 60beats per minute
3 secondary outcomes
Systolic Blood Pressure
Time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Diastolic Blood Pressure
Time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Mean Arterial Pressure
Time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
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 28 Aug 2023.
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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.
Brihaspati K C, MD principal investigator
NAMS Bir Hospital
Brahmadev Jha, MD study chair
NAMS Bir Hospital
Surendra Bhusal, MD study chair
NAMS Bir 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 Normal Saline and Glycopyrrolate in people with Bradyarrhythmia and Cardiac Arrest, run by National Academy of Medical Sciences, Nepal at 1 site in Nepal.
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 28 Aug 2023. 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 Nepal. 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 (Bradycardia) (time frame: Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)). 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 28 Aug 2023.