Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-60
SponsorRawalpindi Institute of Cardiology

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Weighing 40-70kg

ASA III of either sex

Undergoing cardiac surgery with CPB

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Group NalbuphineActive comparator 1 intervention
Group B: Group FentanylActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

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