NCT07435337

Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Rawalpindi Institute of Cardiology · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. A central venous catheter and an arterial line will be inserted under local anesthesia using sterile technique. Before anesthesia induction, patients will receive premedication including midazolam and an opioid pain-relief injection given slowly through the vein. General anesthesia will then be induced with etomidate. After adequate sedation, a muscle relaxant (atracurium) will be administered, and the patient will be ventilated with 100% oxygen using a face mask. The breathing tube will then be inserted and correct placement confirmed. During surgery, anesthesia will be maintained with oxygen, sevoflurane gas, and a continuous atracurium infusion. Hemodynamic parameters such as heart rate and blood pressure will be monitored throughout the peri-intubation and intraoperative period.

Detailed description

Participants will undergo standard preoperative assessment and will receive oral alprazolam 0.5 mg the night before surgery. Intravenous access will be established in the recovery area. Upon arrival in the operating room, standard monitoring will be applied, including non-invasive blood pressure, pulse oximetry, electrocardiography, capnography, and temperature monitoring. Under aseptic conditions and local anesthesia, a central venous catheter will be inserted into the internal jugular vein and an arterial line into the radial artery. Premedication with intravenous midazolam 0.01 mg/kg will be administered and baseline parameters recorded. An opioid analgesic (nalbuphine 0.2 mg/kg or fentanyl 3 µg/kg) will be given intravenously over 5 minutes prior to induction of anesthesia. General anesthesia will be induced with intravenous etomidate 0.3 mg/kg. After adequate sedation, atracurium 0.5 mg/kg will be administered to facilitate neuromuscular blockade, followed by bag-mask ventilation with 100% oxygen. Endotracheal intubation will then be performed under direct laryngoscopy, with confirmation of bilateral air entry and secure fixation of the tube. Anesthesia will be maintained with 60% oxygen in air, sevoflurane (approximately 2 MAC), and a continuous atracurium infusion (5-12 µg/kg/min). Hemodynamic parameters including heart rate and arterial blood pressure will be continuously monitored during the peri-intubation and intraoperative period.

Conditions

• Laryngoscopy
• Hemodynamic Changes

Interventions

Type	Name	Description
DRUG	Nalbuphine	IV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia
DRUG	Fentanyl	3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia

Timeline

• Start date: 2026-02-21
• Primary completion: 2026-05-21
• Completion: 2026-05-21
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Pakistan