Actively Recruiting

Phase 4
Age: 40Years - 60Years
All Genders
Healthy Volunteers
ID07435337

Comparison of Hemodynamic Effects of Nalbuphine Versus Fentanyl in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass at Rawalpindi Institute of Cardiology

Led by Rawalpindi Institute of Cardiology · Updated on 2026-02-27

98

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effects of two opioid drugs, nalbuphine and fentanyl, on the heart and blood pressure responses during laryngoscopy in patients undergoing cardiac surgery with cardiopulmonary bypass. The study is a randomized, double-blinded interventional trial conducted in adults aged 40 to 60 years who are classified as ASA III and undergoing this specific type of surgery. It is conducted by the Rawalpindi Institute of Cardiology and focuses on managing hemodynamic changes during anesthesia. Participants will receive oral alprazolam the night before surgery and have intravenous access established in the recovery area. In the operating room, standard monitoring and the insertion of a central venous catheter and arterial line will be done under local anesthesia. Before anesthesia induction, patients will receive premedication including midazolam and an opioid analgesic, either nalbuphine (0.2 mg/kg) or fentanyl (3 micrograms/kg), given slowly through the vein over 5 minutes. General anesthesia will be induced with etomidate, followed by muscle relaxation with atracurium and ventilation with oxygen. Anesthesia will be maintained with oxygen, sevoflurane gas, and continuous atracurium infusion during surgery. Participants will be closely monitored for heart rate and blood pressure before drug administration, immediately before intubation, and at 1, 3, 5, and 15 minutes after intubation. The study includes routine preoperative assessments and continuous intraoperative monitoring of vital signs and hemodynamic parameters. The total duration of involvement covers preoperative preparation, anesthesia induction, surgery, and monitoring during and shortly after intubation to assess the effects of the drugs on cardiovascular stability.

CONDITIONS

Brief Title

Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

Who Can Participate

Age: 40Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Weighing between 40 and 70 kg
  • ASA physical status classification III
  • Undergoing cardiac surgery with cardiopulmonary bypass
  • Adults aged 40 to 60 years
  • Any sex
Not Eligible

You will not qualify if you...

  • History of drug allergy
  • Pre-existing asthma
  • Renal or hepatic dysfunction
  • Extreme obesity
  • Pregnant or lactating patients
  • Difficult or prolonged intubation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants undergo cardiac surgery with cardiopulmonary bypass and receive either nalbuphine or fentanyl intravenously before anesthesia induction. Hemodynamic parameters are continuously monitored during the peri-intubation and intraoperative period.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi

Rawalpindi, Punjab Province, Pakistan, 46000

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Research Team

A

Ayemon Principal Investigator, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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