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To study the effect of timing of analgesic drug (fentanyl) before giving anaesthesia on heart rate, blood pressure and dose of anaesthetic agent (propofol) in patients undergoing brain tumor surgery.

Effect of timing of fentanyl pretreatment on propofol induction dose and hemodynamic stability in patients undergoing craniotomy for large supratentorial tumours: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110802
Enrollment
76
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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 Health Condition 2: D430- Neoplasm of uncertain behavior ofbrain, supratentorial

Interventions

Intervention1: Fentanyl pre-treatment 5 minutes before induction of anaesthesia: GROUP B (Pretreatment group) will receive fentanyl five minutes prior to induction of anaesthesia with propofol. Contr

Sponsors

DR ANUSHA KAKARLA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status grade I and II patients. Elective craniotomy and excision of a large supratentorial tumour (size of 4cm and above).

Exclusion criteria

Exclusion criteria: Patient drowsy (Glasgow coma score less than 15) Emergency surgery or repeat surgery ASA physical status grade III or more Allergy or contraindications to the study drugs Hepatic failure or renal insufficiency Cardiovascular abnormality and baseline hemodynamic instability Difficult airway (MP Grade III and IV) Patients at risk for aspiration of gastric contents Morbid obesity (BMI more than 40 kg/m2) Pregnant patients Significant midline shift (more than 10 mm) or signs of impending herniation requiring urgent intervention Use of preoperative sedatives or opioids or propofol within 24 hours History of opioid abuse Patient refusal

Design outcomes

Primary

MeasureTime frame
Induction dose of propofol (ml) in both groupsTimepoint: Induction of anaesthesia

Secondary

MeasureTime frame
Heart rate (HR) and mean arterial pressure (MAP)Timepoint: baseline (before giving the first drug), after two minutes of giving the first drug, just before giving the second drug, immediately before intubation, then two and five minutes after endotracheal intubation;Need of esmolol, ephedrine, noradrenaline and atropine.Timepoint: From the administration of the first drug till 5 minutes after intubation.;Patient State Index (PSI) for depth of anaesthesiaTimepoint: Baseline (before giving the first drug), after two minutes of giving the first drug, just before giving the second drug, immediately before intubation, then two and five minutes after endotracheal intubation.;Bilateral regional cerebral oxygenation (rSO2) valuesTimepoint: Baseline (before giving the first drug), after two minutes of giving the first drug, just before giving the second drug, immediately before intubation, then two and five minutes after endotracheal intubation.;Oxygen saturation (SpO2) valuesTimepoint: Baseline (before giving the first drug), after two minutes of giving the first drug, just before giving the second drug, immediately before intubation, then two and five minutes after endotracheal intubation.

Countries

India

Contacts

Public ContactDR MIHIR PRAKASH PANDIA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

pandiamihir@gmail.com09013590548

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026