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Opioid free vs opioid based anesthesia for supratentorial craniotomy

A Randomised controlled single blinded trial to compare Opioid free anesthesia and Opioid based anesthesia in patients undergoing elective craniotomy for Supratentorial lesion - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074828
Enrollment
64
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: D330- Benign neoplasm of brain, supratentorial

Interventions

Intervention1: fentanyl: Fentanyl infusion at1µg/kg/hr starting from induction till closure of dura . Control Intervention1: Dexmedetomidine: Dexmedetomidine infusion 0.5 µg/kg/hr from induction till

Sponsors

Dr Bishnupriya Mohapatra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient belonging to ASA I,II,III Patients with pre operative GCS more than 14 Patient posted for elective supratentorial lesion

Exclusion criteria

Exclusion criteria: Patient posted for emergency craniotomy surgeries 3) Patient belonging to ASA IV and above 4) Patient with bradycardia (Heart rate <60 beats per minute) 5) Patient refusing to consent 6) Patient with chronic pain or on opioid medication 7) Patient with known allergy to study drugs 8) Patients with difficult airway

Design outcomes

Primary

MeasureTime frame
To compare duration to first rescue analgesic requirement in post operative period in patients undergoing supratentorial craniotomy receiving opioid based anesthesia and those receiving opioid free anesthesiaTimepoint: To compare duration to first rescue analgesic requirement in post operative period in patients undergoing supratentorial craniotomy receiving opioid based anesthesia and those receiving opioid free anesthesia

Secondary

MeasureTime frame
compare quality of recovery (QoR- 15) scoreTimepoint: at 1, 6 ,12 , 24 hours post operatively and at discharge;incidence of side effects like bradycardia, tachycardia, hypotension , hypertension, post operative nausea vomiting , pruritus, respiratory depressionTimepoint: post operatively.;post operative pain at 1,2,4,6,12 and 24 hours post operatively.Timepoint: at 1,2,4,6,12 and 24 hours post operatively.;total dose of rescue analgesicTimepoint: post operatively.;total number of propofol bolusTimepoint: intra operatively.

Countries

India

Contacts

Public ContactDr Sanjay Agrawal

AIIMS Rishikesh

sanjay.anaes@aiimsrishikesh.edu.in9761712630

Outcome results

None listed

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