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NCT Number: NCT07435337

Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location status: Recruiting

Location contact

Ayemon Fatima Principal Investigator, MBBS

CONTACT

[email protected]

+92 321 1579066

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nalbuphine

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. Heart Rate

    Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

  2. Systolic Blood Pressure

    Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

  3. Diastolic Blood Pressure

    Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

  4. Mean Blood Pressure

    Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

Study contacts

Contact information is provided by the study sponsor or research team.

Ayemon Principal Investigator, MBBS

CONTACT

[email protected]

+923211579066

Sponsors and collaborators

Lead sponsor

Rawalpindi Institute of Cardiology

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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