Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Laparoscopic Cholecystectomy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202601598052903

Enrollment

110

Registered

2026-01-12

Start date

2025-09-30

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

opoid control anesthesia

opoid free anesthesia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults 18–60 years scheduled for elective laparoscopic cholecystectomy. ASA physical status I or II BMI < 35 kg/m².

Exclusion criteria

Exclusion criteria: Chronic opioid use (>30 MME/day for >3 months). Contraindications to study medications (e.g., severe hepatic impairment; allergy/contraindication to lidocaine, dexmedetomidine, ketamine, fentanyl, or NSAIDs). Renal dysfunction (eGFR <60 mL/min/1.73 m²). Significant cardiac conduction abnormalities. Pregnancy or lactation. Emergency surgery or conversion to open cholecystectomy

Design outcomes

Primary

Measure	Time frame
• Pain intensity at rest (VAS 0–10) at 2 h, 6 h, 12 h, and 24 h postoperatively.	—

Secondary

Measure	Time frame
• Cumulative opioid consumption (MME) 0–24 h and 24–48 h. • Time from end of anesthesia to extubation and to Aldrete =9. • Hemodynamic stability (MAP, HR, SpO2) and postoperative hypoxemia (SpO2 20% change from baseline). • Time to first rescue analgesia (minutes from PACU admission). • Quality of recovery (QoR-40) at 24 h. • Bowel recovery (time to first flatus, hours). • Ambulation tolerance (distance walked at 8 h and 24 h). • Adverse events (respiratory, cardiac) during hospitalization..	—

Measure

Time frame

• Cumulative opioid consumption (MME) 0–24 h and 24–48 h. • Time from end of anesthesia to extubation and to Aldrete =9. • Hemodynamic stability (MAP, HR, SpO2) and postoperative hypoxemia (SpO2 20% change from baseline). • Time to first rescue analgesia (minutes from PACU admission). • Quality of recovery (QoR-40) at 24 h. • Bowel recovery (time to first flatus, hours). • Ambulation tolerance (distance walked at 8 h and 24 h). • Adverse events (respiratory, cardiac) during hospitalization..

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Countries

Egypt

Contacts

Public ContactMohamed AbdelMoneim Bakr Eid

Prof

bakr@aun.edu.eg+201024012615

Outcome results

None listed

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