Skip to content

Comparing different methods of monitoring pain, heart rate and blood pressure with opioid and non opioid medicines in patients undergoing the brain surgeries.

Comparison of changes in Analgesia Nociceptive Index, Surgical Pleth Index, and Hemodynamic parameters to noxious stimuli in patients receiving opioid and opioid free analgesia undergoing supratentorial craniotomies – An open label comparative study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050005
Enrollment
58
Registered
2023-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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: Inj Dexemedetomidine: -Group D – will receive inj dexmedetomidine at 1 mcg/kg iv over 10 min after which the dose will be reduced to 0.5 mcg/kg/hr. Control Intervention1: Inj Fentanyl:

Sponsors

NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients aged between 18 and 65years of ASA I and II -Patients undergoing elective supratentorial craniotomy

Exclusion criteria

Exclusion criteria: -Patients in whom dexmedetomidine is contraindicated (second and third degree heart block), -Patients in whom ANI will be unreliable (patients with pacemakers, patients on drugs affecting sinus node, patients having arrhythmias). -Patients with liver and renal diseases. -Patients on gabapentinoids, tricyclic antidepressants and other analgesics -Patients posted for aneurysmal clipping -Patients with decreased sensorium

Design outcomes

Primary

MeasureTime frame
To compare the magnitude of change and response time in ANI, SPI and hemodynamic parameters (HR and MAP) to various noxious stimuli between patients receiving OFA with dexmedetomidine and those receiving opioid analgesia with fentanyl for supratentorial craniotomies. (Response time is the time taken for the parameter to change maximally due to noxious stimuli from the pre-stimuli value, i.e. lowest for the ANI and highest for SPI, HR and BP) (Magnitude of change is the difference between highest/lowest value after stimulation as compared to baseline i.e. pre-stimuli value)Timepoint: Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.

Secondary

MeasureTime frame
-To compare the magnitude of change and response timein ANI, SPI, hemodynamics with in the group -To determine and correlation between ANI and SPI in patients receiving opioid and OFATimepoint: Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.

Countries

India

Contacts

Public ContactSONIA BANSAL

National Institute of Mental Health and Neurosciences, Bengaluru

itz.sonia77@gmail.com

Outcome results

None listed

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