Nalbuphine versus fentanyl to reduce blood pressure and heart rate changes during laryngoscopy and intubation
COMPARISON OF HEMODYNAMIC EFFECTS OF NALBUPHINE VERSUS FENTANYL: A RANDOMIZED, DOUBLE-BLINDED INTERVENTIONAL STUDY IN PATIENTS ON CARDIOPULMONARY BYPASS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI
This test sees if nalbuphine or fentanyl better prevents spikes in heart rate and blood pressure during intubation for people having cardiac surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Rawalpindi Institute of Cardiology Academic / other |
| Locations | 1 site (Rawalpindi, Punjab Province) |
| Trial ID | NCT07435337 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for cardiac surgery will receive standard premedication and invasive monitoring including central venous and arterial lines, then be given either nalbuphine (0.2 mg/kg) or fentanyl (3 µg/kg) intravenously before induction with etomidate and muscle relaxation with atracurium. Endotracheal intubation will be performed under direct laryngoscopy and hemodynamic parameters (heart rate and arterial blood pressure) will be recorded continuously around the time of laryngoscopy and during the intraoperative period. Anesthesia will be maintained with sevoflurane and a continuous atracurium infusion while measurements are compared between the two opioid groups to determine which drug better blunts the laryngoscopic stress response. Standard exclusion criteria include asthma, significant renal or hepatic dysfunction, extreme obesity, pregnancy or lactation, and anticipated difficult or prolonged intubation.
Who should consider this trial
Good fit: Ideal candidates are adults ASA III weighing 40–70 kg who are scheduled for cardiac surgery with cardiopulmonary bypass and meet the trial's inclusion and exclusion criteria.
Not a fit: Patients with pre-existing asthma, significant renal or hepatic dysfunction, extreme obesity, pregnancy or lactation, or anticipated difficult intubation are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, the preferred opioid could reduce dangerous blood pressure and heart rate spikes during intubation, improving hemodynamic stability and potentially lowering perioperative complications.
How similar studies have performed: Fentanyl and other opioids are well established to blunt laryngoscopy-induced hemodynamic responses, while nalbuphine has been less widely studied but some smaller trials suggest similar effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Weighing 40-70kg * ASA III of either sex * Undergoing cardiac surgery with CPB Exclusion Criteria: • History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant / lactating patients • Difficult intubation/prolonged intubation
Where this trial is running
Rawalpindi, Punjab Province
- Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi — Rawalpindi, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Ayemon Principal Investigator, MBBS
- Email: ayemonfatima@gmail.com
- Phone: +923211579066
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.