Using nebulized Dexmedetomidine to reduce heart rate and blood pressure during anesthesia.
Preoperative Dexmedetomidine Nebulization in Blunting Hemodynamic Stress Response to Laryngoscopy
PHASE4 · Pakistan Institute of Medical Sciences · NCT06103721
This study tests if using a mist of Dexmedetomidine can help lower heart rate and blood pressure in patients having surgery under general anesthesia.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Pakistan Institute of Medical Sciences (other gov) |
| Locations | 1 site (Islamabad, Federal) |
| Trial ID | NCT06103721 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of nebulized Dexmedetomidine in mitigating the hemodynamic responses, such as increased heart rate and blood pressure, that occur during direct laryngoscopy and endotracheal intubation in patients undergoing general anesthesia. The study will include patients aged 16 and older, classified as ASA class I, II, or III, who are scheduled for elective surgeries requiring general anesthesia. Participants will receive either nebulized Dexmedetomidine or normal saline prior to intubation to assess the drug's impact on their cardiovascular stability. The goal is to enhance patient safety, particularly for those with pre-existing cardiac conditions.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and older undergoing elective surgeries under general anesthesia with ASA class I, II, or III.
Not a fit: Patients who are pregnant, have a BMI over 35, or suffer from liver or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cardiovascular stability during anesthesia, reducing risks for patients with heart conditions.
How similar studies have performed: Other studies have shown that similar approaches using Dexmedetomidine can effectively manage hemodynamic responses, suggesting potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 16 years and above. * American Society of Anesthesiologists (ASA) class: I, II and III. * Elective surgeries under General Endotracheal Anesthesia. * Potentially difficult airway. Exclusion Criteria: * Pregnancy * Body mass index \>35 kg/m2 * Known allergy to drugs used in the study * Liver and renal insufficiency
Where this trial is running
Islamabad, Federal
- Deparment of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences — Islamabad, Federal, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Muhammad Haroon Anwar, MBBS — Department of Anesthesia and Critical Care, Pakistan Institute of Medical Sciences, Islamabad
- Study coordinator: Muhammad Haroon Anwar, MBBS
- Email: haroonanwar22@gmail.com
- Phone: +92-333-5236956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemodynamic Instability, Dexmedetomidine, Stress response to laryngoscopy, General Anaesthesia, Direct Laryngoscopy