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Opioid versus alternative drug for pain management during brain surgery

Non-opioid versus Opioid Perioperative Analgesia In Neurosurgery: A prospective Multi-centric Randomized Controlled Trial (NO PAIN Trial) - NOPAIN

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045705
Enrollment
500
Registered
2022-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: Dexmedetomidine: Dexmedetomidine 0.5 mcg/kg/h will be administered as continuous infusion after anesthetic induction till end of surgery. Control Intervention1: Fentanyl: Fentanyl will

Sponsors

Sriganesh Kamath
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive consenting adult patients undergoing elective craniotomies for supratentorial brain tumors with Glasgow Coma Scale score of 15 will be included in this trial.

Exclusion criteria

Exclusion criteria: We will exclude patients from this trial if they do not consent or if they have a current or past history of ischemic heart disease, cardiac failure (New York Heart Association grade >= 3), heart block or arrhythmia, untreated hypertension and diabetes mellitus, emergency surgery, pre-existing pain and receiving regular long-term drugs to manage pain, history of vomiting, previous cranial surgery, allergy to study drugs and opioid dependence as per the Diagnostic and Statistical Manual of mental disorders IV criteria.

Design outcomes

Primary

MeasureTime frame
1.Rescue fentanyl consumption during surgery 2.Postoperative pain using Numerical Rating Scale score Timepoint: 1.During surgery 2.After surgery

Secondary

MeasureTime frame
Adverse eventsTimepoint: During and upto 60 minutes after surgery;Patient satisfactionTimepoint: 24 hours after surgery;Persistent pain and quality of lifeTimepoint: At 3 and 6 months after surgery;Quality of recovery from anesthesia and emergence deliriumTimepoint: End of anesthesia till 60 minutes after surgery;Quality of sleepTimepoint: 1st postoperative day

Countries

India

Contacts

Public ContactSriganesh Kamath

National Institute of Mental Health and Neurosciences, Bengaluru

drsri23@gmail.com08026995415

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 6, 2026