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Effect of intravenous fentanyl vs intravenous morphine on hemodynamic stability and anesthetic requirement in patients undergoing surgery for oral cancers

A comparison of Intraoperative hemodynamic stability and anesthetic requirement using intravenous morphine vs Fentanyl: A prospective randomized study in patients undergoing composite resection and reconstruction for head and neck malignancies. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097249
Enrollment
59
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intravenous Fentanyl group (Group F): Patients in Group F will receive 1.5mcg/kg of Fentanyl Bolus. In Group F, fentanyl infusion at the rate of 0.25mcg/kg/hr. It will be continued intr

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American Society of Anaesthesiologists (ASA) Physical Status I to III, i.e.: • ASA I: Normal healthy individuals. • ASA II: Patients with mild systemic disease (e.g., controlled hypertension, controlled diabetes). • ASA III: Patients with severe systemic disease that is not incapacitating but limits activity (e.g., controlled cardiac or respiratory disease). Surgical procedure: Patients scheduled for elective composite resection and reconstruction surgery for head and neck malignancies under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Patients who have BMI 35 2. Individuals with developmental or cognitive impairments that may hinder their ability to provide informed consent. 3. Pregnant or breastfeeding women. 4. Known allergies or hypersensitivity to morphine or fentanyl 5. Previous adverse reactions or complications associated with the use of either opioids. Patients with chronic opioid use or opioid tolerance

Design outcomes

Primary

MeasureTime frame
To systematically evaluate and compare the impact of intravenous morphine and fentanyl on hemodynamic response during composite resection and reconstruction surgeryTimepoint: At Baseline 1 minute after skin incision 5 minutes after skin incision 15minutes 30 minutes 45 minutes 60 minutes 90 minutes 120 minutes 150 minutes 180 minutes 210 minutes 240 minutes 270 minutes 300 minutes 330 minutes 360 minutes 390 minutes 420 minutes

Secondary

MeasureTime frame
To evaluate the total anesthetic requirements, including the total dose of intraoperative fentanyl & sevoflurane consumption in patients receiving intravenous morphine compared to those receiving fentanyl during the surgical procedure. To analyze & compare the intraoperative hemodynamic fluctuations, including episodes of hypertension/ hypotension, Tachycardia/Bradycardia associated with the use of intravenous morphine versus fentanyl during composite resection & reconstruction surgery.Timepoint: at Baseline 1 minute after skin incision 5 minutes after skin incision 15minutes 30 minutes 45 minutes 60 minutes 90 minutes 120 minutes 150 minutes 180 minutes 210 minutes 240 minutes 270 minutes 300 minutes 330 minutes 360 minutes 390 minutes 420 minutes

Countries

India

Contacts

Public ContactG Aravind

Nizams Institute of Medical Sciences

karakshay@gmail.com8143385838

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026