Skip to content

Effect of Analgesia Nociception Index (ANI) Monitoring on Intraoperative Analgesia Management During Elective Hepatobiliary Surgeries

Effect of Analgesia Nociception Index (ANI) Monitoring on Intraoperative Analgesia Management During Elective Hepatobiliary Surgeries: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202601508836060
Enrollment
170
Registered
2026-01-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Anaesthesia

Interventions

Hemodynamic Guided Analgesia
ANI Guided Analgesia

Sponsors

national liver institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Adult patients aged 18- 75 years of both sexes. • ASA physical status I–III. • BMI <35 kg/m². • Patients scheduled for elective hepatobiliary surgery under general anesthesia • Duration of surgery 2-4 hours. • Ability to understand and provide informed consent.

Exclusion criteria

Exclusion criteria: • Patient refusal. • Cardiac arrhythmias interfering with ANI (e.g., atrial fibrillation) (9) • Pacemaker dependency (9) • Chronic opioid use (>3 months daily opioid use or opioid tolerance) (10) • Severe hepatic or renal failure (Child C or eGFR 35 kg/m² (if concerned for reliable ANI signal) (13) • Use of medications affecting autonomic balance within 24 h (e.g. high beta-blockers and anticholinergic drugs) • Pregnancy • Known allergy to study drugs

Design outcomes

Primary

MeasureTime frame
total intraoperative opioid consumption (in µg fentanyl equivalents) between the ANI-guided analgesia group and the hemodynamic-guided group.

Secondary

MeasureTime frame
1. To compare intraoperative hemodynamic stability (episodes of hypotension/bradycardia, hypertension/tachycardia), and vasoactive drug usage between groups. 2. To assess postoperative pain by (VAS) score . 3. To compare postoperative opioid consumption (nalbuphine equivalents) within 24 h. 4. To assess time to extubation, time to PACU discharge, incidence of PONV (post-operative nausea and vomiting) and sedation score at PACU. 5. To evaluate adverse events related to analgesic management (respiratory depression, over-sedation, hemodynamic instability).

Countries

Egypt

Contacts

Public Contacthanaa rashed

anasthesia lecturer

hanaarashed2020@yahoo.com01001378542

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026