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To find out how of the use of either Remifentanil or Fentanyl with Propofol-based anesthesia has effect on easier awakening from anaesthesia & patient stability during a Craniotomy.

Evaluation of the effect of Remifentanil vs Fentanyl as an adjunct to Propofol-based TIVA on Ease of Emergence & Intraoperative Haemodynamic Stability in patients undergoing Craniotomy : A Randomised Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078692
Enrollment
66
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: Remifentanil Infusion: Patients allocated to this group will receive Remifentanil TCI infusion based on body weight, height, age and sex, to meet a target plasma concentration of 6-8 ng

Sponsors

Institute of Neurosciences Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I, II, III Either gender BMI less than35 kg/m2 Any craniotomy for both supra-tentorial & infra-tentorial space occupying lesion GCS of 15/15 Duration of surgery of 4 hr

Exclusion criteria

Exclusion criteria: Patient refusal body mass index more than 35 kg/m2, GCS less than 15/15 H/o previous craniotomy If rapid postoperative return to normal consciousness was unlikely, owing to the location or size of lesion or postoperative ventilation is planned uncontrolled hypertension/ significant CAD/ cardiac conduction block/ severe renal dysfunction/ CLD/ chronic obstructive pulmonary disease (GOLD 3/4) / neuropsychiatric disorders chronic pain requiring opioid analgesia, reported allergy to either study drug, patients having awake craniotomies or craniotomies requiring intraoperative CT/ magnetic resonance scanning (because the length of surgery will be much longer).

Design outcomes

Primary

MeasureTime frame
Ease of extubation: 1.Time to eye opening 2.Time to extubation 3.Cough 4.Sedation 5.PainTimepoint: During extubation ( 0 min)

Secondary

MeasureTime frame
Heart rateTimepoint: At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr;Systolic blood pressureTimepoint: At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr;Diastolic blood pressureTimepoint: At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr;Mean arterial blood pressureTimepoint: At induction of anesthesia, head pinning, incision, during burring, 30 min, 1 hr,2 hr, 3 hr, 4 hr

Countries

India

Contacts

Public ContactDr Eesha Banerjee

Institute of Neurosciences Kolkata

kalloldeb15@gmail.com9830028915

Outcome results

None listed

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