Skip to content

Implementing Enhanced Recovery After Surgery: A Randomized Controlled Trial of Surgical Pleth Index-Guided Opioid-Free Anesthesia in Laparoscopic General Surgery

Implementing Enhanced Recovery After Surgery: A Randomized Controlled Trial of Surgical Pleth Index-Guided Opioid-Free Anesthesia in Laparoscopic General Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120606
Enrollment
Unknown
Registered
2026-03-17
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

None

Interventions

OPA group:Conventional opioid-based anesthesia
SPI-OFA group:Surgical Pleth Index (SPI)-guided opioid-free anesthesia

Sponsors

Ningbo Medical Centre Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 75 years. ,ASA physical status I or II; 2.Scheduled for an elective laparoscopic general surgical procedure (e.g., cholecystectomy, appendectomy, inguinal hernia repair); 3.Provided voluntary written informed consent.

Exclusion criteria

Exclusion criteria: 1.Severe dysfunction of the heart, lungs, liver, or kidneys; 2.History of chronic pain or long-term use of opioids/sedatives; 3.Known allergy or contraindication to any study medication (e.g., propofol, remifentanil, dexmedetomidine, lidocaine, esketamine, NSAIDs); 4.Severe arrhythmia or peripheral vascular disease potentially affecting SPI signal quality; 5.Psychiatric or cognitive impairment preventing cooperation with postoperative assessments; 6.Pregnancy or lactation; 7.Body mass index (BMI) > 35 kg/m^2.

Design outcomes

Primary

MeasureTime frame
Incidence of nausea and vomiting, respiratory depression, and pruritus;Frequency of intraoperative rescue interventions;QoR-15 score at 24 hours postoperatively;

Secondary

MeasureTime frame
Postoperative tramadol consumption;Dosage of opioids (sufentanil, remifentanil) and esketamine, along with the number of administrations and dosage of vasoactive drugs;Protocol deviation rate;Postoperative pain NRS score;Mean Arterial Pressure,Heart Rate and Surgical Pleth Index;

Countries

China

Contacts

Public ContactZhang Ying

Ningbo Medical Centre Lihuili Hospital

370604962@qq.com+86 574 87018627

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026