Effect of Nalbuphine on Hemodynamic Response During Laryngoscopy and Intubation (NCT07348159) | Clinical Trial Compass
CompletedNot Applicable
Effect of Nalbuphine on Hemodynamic Response During Laryngoscopy and Intubation
Pakistan107 participantsStarted 2024-03-01
Plain-language summary
Laryngoscopy and placement of a breathing tube during general anesthesia can cause temporary increases in blood pressure and heart rate. These changes may be harmful in some patients. Nalbuphine is an opioid pain medicine that may reduce these cardiovascular responses.
This study evaluated whether intravenous nalbuphine, given before anesthesia induction, reduces changes in mean arterial blood pressure during laryngoscopy and orotracheal intubation compared with placebo (normal saline).
Adult patients undergoing elective surgery under general anesthesia were randomly assigned to receive either nalbuphine or placebo before anesthesia. Blood pressure was measured before drug administration, during intubation, and for several minutes afterward. The results of this study may help guide safe medication use to maintain blood pressure stability during airway management.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients scheduled for elective surgery under general anesthesia requiring laryngoscopy and orotracheal intubation.
American Society of Anesthesiologists (ASA) physical status I or II. Age between 18 and 60 years. Both male and female patients. Patients who provide written informed consent.
Exclusion Criteria:
Known hypersensitivity to nalbuphine or any opioids. History of cardiovascular disease, including uncontrolled hypertension, arrhythmias, or ischemic heart disease.
Patients with respiratory disorders such as asthma, chronic obstructive pulmonary disease, or significant respiratory compromise.
Patients with renal or hepatic impairment. Pregnant or lactating women. Patients on medications affecting hemodynamic response (e.g., beta-blockers, calcium channel blockers).
Emergency surgeries. Patients with anticipated difficult airway (Mallampati class III or IV).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Arterial Pressure (MAP) change following laryngoscopy and orotracheal intubation
Timeframe: Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation