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Comparison of Analgesia Nociception Index (ANI) guided opioid administration on postoperative pain score, opioid requirement and stress response in children undergoing cochlear implant surgery

Effect of perioperative Analgesia Nociception Index (ANI) guided opioid administration on postoperative pain score, opioid consumption and endocrine stress response in paediatric patients undergoing cochlear implant surgery: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036412
Enrollment
68
Registered
2021-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Analgesia Nociception Index tool guided opioid administration: IV fentanyl 1mcg/kg will be administered when mean ANI value is less than 50 and repeated every 5 minutes until it is more

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA 1 and 2 2.Scheduled for elective cochlear implant

Exclusion criteria

Exclusion criteria: 1.Severe cardiac/respiratory disease 2.Parental refusal

Design outcomes

Primary

MeasureTime frame
To determine whether use of Analgesia Nociception Index (ANI) guided perioperative opioid administration results in decrease in FLACC scale score postoperativelyTimepoint: from the start of surgery to upto 90 minutes in post anaesthesia care unit—

Secondary

MeasureTime frame
To compare ANI-guided vs hemodynamic parameter guided opioid administration on: 1.Total fentanyl consumption 2.Endocrine stress response during surgery 3.Incidence of emergence deliriumTimepoint: from the start of surgery to upto 90 minutes in post anaesthesia care unit—

Countries

India

Contacts

Public ContactGajalakshmi Sanjeevi

All India Institute of Medical Sciences

drsrajeshwari@gmail.com9810079229

Outcome results

None listed

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