Coronary Artery Bypass GraftingNCT06637956
The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery
A study testing Nitroglycerin (NTG) in people with Coronary Artery Bypass Grafting, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Coronary Artery Bypass Grafting
- What is being tested?
- Nitroglycerin (NTG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Patients undergoing coronary artery bypass grafting surgery.
- Patients aged 35-60 years.
- Ejection Fraction between 50-60%.
- American Society of Anesthesiologists Classification 3-4.
Who cannot join
- Known hypersensitivity to nitroglycerin.
- Anticipated difficult airway.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Anesthesia, Rashid Latif Medical College
Lahore, Punjab Province
About this study
Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. However, nitroglycerin is the most widely utilized medicine due to its fast effect, short half-life, and absence of sedative qualities.
Read the detailed description
The circulatory system under compromise is less resilient to the effects of general anaesthesia. Inducing anaesthesia is a crucial step for cardiac patients because their impaired circulatory systems are less tolerant to depression. During coronary artery bypass grafting surgery, the primary objective of general anesthesia is to reduce sympathetic response to uncomfortable stimuli, including laryngoscopy, intubation, skin incision, sternal splitting, and spreading. A rise in blood pressure is one of the hemodynamic reactions that is typically associated with tracheal intubation and laryngoscopy. The impact of intra nasally delivered nitroglycerin on blood pressure response to laryngoscopy and intubation in patients having non-cardiac surgery is currently contentious; however, this study focus on coronary artery bypass grafting surgery patients.
- Conditions
- Coronary Artery Bypass Grafting
- Being tested
- Nitroglycerin (NTG)
- Keywords
- Intranasal, nitroglycerin, hemodynamic response, larayngoscopy, intubation, coronary artery bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin (NTG)Drug
Received 1 mg of nitroglycerin intranasally two minutes prior to laryngoscopy and intubation
| Study group | Role | What they receive |
|---|---|---|
| NTG | Experimental | Received a mg nitroglycerin intranasally two minutes prior to laryngoscopy and intubation Receives: Drug: Nitroglycerin (NTG) |
| Control | No intervention | Control group did not receive nitroglycerine prior to laryngoscopy and intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean aterial pressure
Mean arterial pressure was measured prior to and after intubation
Measured: 5 minutes post intubation
Heart rate
Heart rate was measure prior to and after intubation
Measured: 5 minutes post intubation
Systolic blood pressure
Systolic blood pressure was measure prior to and after itubation
Measured: 5 minutes post intubation
Diastolic blood pressure
Diastolic blood pressure was measure prior to and after intubation
Measured: 5 minutes post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Shehryar Ahmed, MS, Principal investigator, Department of anesthesia Rashid Latif Medical college, Lahore, PakistanSyed Shakeel Ahmed, FCPS, Principal investigator, Department of Anesthesia, Shahida Islam Teaching Hospital, Lodhran, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637956
- Sponsor's protocol ID
- PIC_Lahore
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery
- ClinicalTrials.gov ID
- NCT06637956
- Acronym / sponsor ID
- PIC_Lahore
- Conditions
- Coronary Artery Bypass Grafting
- Keywords
- Intranasal, nitroglycerin, hemodynamic response, larayngoscopy, intubation, coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Oct 2024 (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.
Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. However, nitroglycerin is the most widely utilized medicine due to its fast effect, short half-life, and absence of sedative qualities.
Detailed description
The circulatory system under compromise is less resilient to the effects of general anaesthesia. Inducing anaesthesia is a crucial step for cardiac patients because their impaired circulatory systems are less tolerant to depression. During coronary artery bypass grafting surgery, the primary objective of general anesthesia is to reduce sympathetic response to uncomfortable stimuli, including laryngoscopy, intubation, skin incision, sternal splitting, and spreading. A rise in blood pressure is one of the hemodynamic reactions that is typically associated with tracheal intubation and laryngoscopy. The impact of intra nasally delivered nitroglycerin on blood pressure response to laryngoscopy and intubation in patients having non-cardiac surgery is currently contentious; however, this study focus on coronary artery bypass grafting surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTG | Experimental | Drug: Nitroglycerin (NTG)Received a mg nitroglycerin intranasally two minutes prior to laryngoscopy and intubation |
| Control | No intervention | –Control group did not receive nitroglycerine prior to laryngoscopy and intubation |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both genders
- Patients undergoing coronary artery bypass grafting surgery.
- Patients aged 35-60 years.
- Ejection Fraction between 50-60%.
- American Society of Anesthesiologists Classification 3-4.
Key exclusion criteria (3 listed)
- Known hypersensitivity to nitroglycerin.
- Anticipated difficult airway.
- Emergency surgery.
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 |
|---|---|---|
| Nitroglycerin (NTG)Received 1 mg of nitroglycerin intranasally two minutes prior to laryngoscopy and intubation | Drug | NTG |
Primary outcome
Mean aterial pressure
Time frame: 5 minutes post intubation
Mean arterial pressure was measured prior to and after intubation
Heart rate
Time frame: 5 minutes post intubation
Heart rate was measure prior to and after intubation
Systolic blood pressure
Time frame: 5 minutes post intubation
Systolic blood pressure was measure prior to and after itubation
Diastolic blood pressure
Time frame: 5 minutes post intubation
Diastolic blood pressure was measure prior to and after intubation
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
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.
Shehryar Ahmed, MS principal investigator
Department of anesthesia Rashid Latif Medical college, Lahore, Pakistan
Syed Shakeel Ahmed, FCPS principal investigator
Department of Anesthesia, Shahida Islam Teaching Hospital, Lodhran, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin (NTG) in people with Coronary Artery Bypass Grafting, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 3 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 15 Oct 2024. 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 Pakistan. 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 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?
Mean aterial pressure (time frame: 5 minutes post intubation). The study lists 4 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 15 Oct 2024.