Non Opioid Perioperative Analgesia In Neurosurgery (NO PAIN)

Non Opioid Perioperative Analgesia In Neurosurgery - NO PAIN

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010833

Enrollment

Registered

2017-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: G891- Acute pain, not elsewhere classified Health Condition 2: null- patients undergoing craniotomy for decompression of brain tumor

Interventions

Intervention1: dexmedetomidine: dexmedetomidine in the dose of 0.5-1 mcg/kg/h will be administered during surgery Control Intervention1: Fentanyl: Fentanyl in the dose of 1-2 mcg/kg/h will be administ

Eligibility

Inclusion criteria

Inclusion criteria: scheduled for elective craniotomy for supratentorial tumors at NIMHANS, Bengaluru

Exclusion criteria

Exclusion criteria: patients with current or recent history of ischemic heart disease, cardiac failure (NYHA grade >= 3), heart block or arrhythmia, patients with uncontrolled hypertension and diabetes mellitus despite treatment, emergency surgeries, co-existing chronic painful conditions receiving long term pain medications on a daily basis, history of motion sickness, previous craniotomy, and opioid dependence

Design outcomes

Primary

Measure	Time frame
Feasibility of recruiting 80% of study sampleTimepoint: 4 months	—

Secondary

Measure	Time frame
Biomarkers of surgical stress (serum cortisol, blood glucose, arterial blood gas and hematological parameters)Timepoint: Before and after surgery;Core body temperatureTimepoint: Every 15 min during surgery;Incidence of perioperative adverse eventsTimepoint: Intraoperative period and immediate postoperative period;Pain scoreTimepoint: 3, 6, and 12 months;Postoperative NRS score for painTimepoint: At 15 minutes into PACU admission, day 1, 2 and 3 after surgery;Recovery characteristicsTimepoint: At extubation;Surgical Pleth IndexTimepoint: Every 15 min during craniotomy;Total bolus dose of fentanyl administeredTimepoint: intraoperative period	—

Measure

Time frame

Biomarkers of surgical stress (serum cortisol, blood glucose, arterial blood gas and hematological parameters)Timepoint: Before and after surgery;Core body temperatureTimepoint: Every 15 min during surgery;Incidence of perioperative adverse eventsTimepoint: Intraoperative period and immediate postoperative period;Pain scoreTimepoint: 3, 6, and 12 months;Postoperative NRS score for painTimepoint: At 15 minutes into PACU admission, day 1, 2 and 3 after surgery;Recovery characteristicsTimepoint: At extubation;Surgical Pleth IndexTimepoint: Every 15 min during craniotomy;Total bolus dose of fentanyl administeredTimepoint: intraoperative period

—

Countries

India

Contacts

Public ContactSriganesh K

National Institute of Mental Health and Neurosciences

drsri23@gmail.com9481445949

Outcome results

None listed

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