Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

NCT07435337 | Recruiting Phase 4 DMC

• 1 other identifier: RIC/RERC/29/26
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngoscopy; Hemodynamic Changes

Keywords

Laryngoscopic stress response

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Group Nalbuphine

ACTIVE COMPARATOR

Participants will receive an injection of nalbuphine 0.2 mg/kg intravenous slowly over 5 minutes before induction.

Drug: Nalbuphine

Group Fentanyl

ACTIVE COMPARATOR

Participants will receive an injection of fentanyl 3 µg/kg intravenous slowly over 5 min before induction.

Drug: Fentanyl

Interventions

Nalbuphine DRUG

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

Group Nalbuphine

Fentanyl DRUG

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

Group Fentanyl

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weighing 40-70kg
• ASA III of either sex
• Undergoing cardiac surgery with CPB

You may not qualify if:

• History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant / lactating patients • Difficult intubation/prolonged intubation

Sponsors & Collaborators

• Rawalpindi Institute of Cardiology: lead

Study Sites (1)

Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Interventions

Nalbuphine; Fentanyl

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Qudsia Qureshi, MBBS

  Head of Department of Anesthesia

  STUDY CHAIR

Central Study Contacts

Ayemon Principal Investigator, MBBS

CONTACT

+923211579066; ayemonfatima@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 21, 2026
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)