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Remifentanil Dose Finding Study to Attenuate intubation response

Comparative study of different doses of Remifentanil in attenuating intubation response under BIS monitoring

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250815001
Enrollment
240
Registered
2025-08-15
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

adult surgical patients Remifentanil Endotracheal Intubation Hemodynamics Bispectral Index Anesthesia Clinical Trials

Interventions

Anesthesia will be induced with propofol 2 mg per kg and vecuronium 0.10 mg per kg. Once the TOF ratio becomes 0, intravenous Remifentanil will be administered over 60 seconds according to the patient
s assigned group. Group 1 , sample size 80, Patients in this arm will receive Remifentanil 0.5 mcg per kg intravenously.,Anesthesia will be induced with propofol 2 mg per kg and vecuronium 0.10 mg pe
s assigned group. Patients in this arm will receive Remifentanil 1 mcg per kg intravenously.,Anesthesia will be induced with propofol 2 mg per kg and vecuronium 0.10 mg per kg. Once the TOF ratio beco
s assigned group. Patients in this arm will receive Remifentanil 1.5 mcg per kg intravenously.
Experimental Drug,Experimental Drug,Experimental Drug
Remifentanil 0.5 mcg per kg,Remifentanil 1.0 mcg per kg,Remifentanil 1.5 mcg per kg

Sponsors

Aleena Wilson
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Adult surgical patients 2. Age 18 to 60 years 2. Undergoing elective surgery under general anesthesia 3. Classified as ASA Physical Status I or II

Exclusion criteria

Exclusion criteria: 1. uncontrolled co-morbidities (hypertension, diabetes, hypothyroidism, or hypotension) 2. Obesity 3. Chronic therapy with benzodiazepines, opioids, anticonvulsants, or alpha-adrenergic agonists. 4. Patients with a known allergy to opioids, Propofol, or Vecuronium 5. Patients with an anticipated difficult airway.

Design outcomes

Primary

MeasureTime frame
hemodynamic response every 2 min changes in heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP)

Secondary

MeasureTime frame
bispectral index (BIS) values during intubation at the time of intubation Bi-spectral index

Countries

India

Contacts

Public ContactAleena Wilson

Tata Main Hospital, Jamshedpur

aleena.wilson@tatasteel.com6266816224

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026