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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07435337
Enrollment
98
Registered
2026-02-27
Start date
2026-02-21
Completion date
2026-05-21
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Changes, Laryngoscopy

Keywords

Laryngoscopic stress response

Brief 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.

Interventions

DRUGNalbuphine

IV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia

DRUGFentanyl

3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia

Sponsors

Rawalpindi Institute of Cardiology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Diastolic Blood PressureBefore administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Mean Blood PressureBefore administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Heart RateBefore administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Systolic Blood PressureBefore administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

Countries

Pakistan

Contacts

CONTACTAyemon Principal Investigator, MBBS
ayemonfatima@gmail.com+923211579066
STUDY_CHAIRQudsia Qureshi, MBBS

Head of Department of Anesthesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026