- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06637956
The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery
October 9, 2024 updated by: Muhammad Aamir Latif
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Department of Anesthesia, Rashid Latif Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known hypersensitivity to nitroglycerin.
- Anticipated difficult airway.
- Emergency surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NTG
Received a mg nitroglycerin intranasally two minutes prior to laryngoscopy and intubation
|
Received 1 mg of nitroglycerin intranasally two minutes prior to laryngoscopy and intubation
|
|
No Intervention: Control
Control group did not receive nitroglycerine prior to laryngoscopy and intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean aterial pressure
Time Frame: 5 minutes post intubation
|
Mean arterial pressure was measured prior to and after intubation
|
5 minutes post intubation
|
|
Heart rate
Time Frame: 5 minutes post intubation
|
Heart rate was measure prior to and after intubation
|
5 minutes post intubation
|
|
Systolic blood pressure
Time Frame: 5 minutes post intubation
|
Systolic blood pressure was measure prior to and after itubation
|
5 minutes post intubation
|
|
Diastolic blood pressure
Time Frame: 5 minutes post intubation
|
Diastolic blood pressure was measure prior to and after intubation
|
5 minutes post intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shehryar Ahmed, MS, Department of anesthesia Rashid Latif Medical college, Lahore, Pakistan
- Principal Investigator: Syed Shakeel Ahmed, FCPS, Department of Anesthesia, Shahida Islam Teaching Hospital, Lodhran, Pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
October 7, 2024
First Submitted That Met QC Criteria
October 9, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 9, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIC_Lahore
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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