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

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.

Study Overview

• Status: Recruiting
• Conditions: Laryngoscopy; Hemodynamic Changes
• Intervention / Treatment: Drug: Nalbuphine; Drug: Fentanyl

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.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ayemon Principal Investigator, MBBS; Phone Number: +923211579066; Email: ayemonfatima@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Recruiting
      • Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi
      • Contact: Ayemon Fatima Principal Investigator, MBBS; Phone Number: +92 321 1579066; Email: ayemonfatima@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Nalbuphine; Participants will receive an injection of nalbuphine 0.2 mg/kg intravenous slowly over 5 minutes before induction.	Drug: Nalbuphine; IV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia
Active Comparator: Group Fentanyl; Participants will receive an injection of fentanyl 3 µg/kg intravenous slowly over 5 min before induction.	Drug: Fentanyl; 3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart Rate	Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Systolic Blood Pressure	Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Diastolic Blood Pressure	Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Mean Blood Pressure	Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation

Collaborators and Investigators

• Sponsor: Rawalpindi Institute of Cardiology
• Investigators: Study Chair: Qudsia Qureshi, MBBS, Head of Department of Anesthesia

Publications and helpful links

General Publications

• Saiyed A, Sharma S, Hussain A. Comparison of analgesic and hemodynamic effects of nalbuphine versus fentanyl: a randomized, double-blinded interventional study in patients on cardiopulmonary bypass. Egypt J Cardiothorac Anesth. 2020;14(2):44.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2026
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Laryngoscopic stress response
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Fentanyl; Nalbuphine
• Other Study ID Numbers: RIC/RERC/29/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Hospital ethical committe doesnt allow data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No