Opioid-free anesthesia versus opioid-based anesthesia in bariatric surgery - a randomized controlled trial

Opioid-free anesthesia versus opioid-based anesthesia in bariatric surgery - a randomized controlled trial - OpFree

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031405

Enrollment

172

Registered

2023-03-06

Start date

2023-07-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E66.0

Interventions

Group 1: Opioid-free anesthesia - multimodal general anesthesia using dexmedetomidine, lidocaine, propofol, esketamine, dexamethasone, metamizole, ibuprofen, and magnesium. Group 2: Opioid-based anest

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for primary bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass)

Exclusion criteria

Exclusion criteria: - Previous bariatric surgery - Allergies to drugs of the study protocol - Sinuatrial of atrioventricular block - Chronic heart failure with reduced ejection fraction 60 kg/m2

Design outcomes

Primary

Measure	Time frame
- Time to achieve a White Fast Track score of = 12 points	—

Secondary

Measure	Time frame
- Heart rate variability - BIS at defined time points - NOL index at defined time points - Need for vasoactive medications - Need for opioid administration in the intervention group (Arm A) - Time from end of suture to extubation - Postoperative nausea and vomiting (PONV) 2h and 22-26h after extubation - Need for antiemetic medication - Postoperative pain (NRS) 2h or 22-26h after extubation - Drop in oxygen saturation (SpO2 < 92%) for longer than 30 seconds or need for oxygen in the post anesthesia care unit - Postoperative pulmonary complications - Postoperative atelectasis and inhomogeneity of pulmonary ventilation - Length of stay in the post anesthesia care unit - Opioid requirements within 24 h after extubation - Quality of Recovery 40-score (QoR-40) - Time to first postoperative bowel movement - Hospital length of stay - Drinking quantity on postoperative day 1 - Postoperative morbidity up to day 30 as measured by the Comprehensive Complication Index (CCI) - Occurrence of defined adverse events intraoperatively - Occurrence of defined adverse events postoperatively	—

Measure

Time frame

- Heart rate variability - BIS at defined time points - NOL index at defined time points - Need for vasoactive medications - Need for opioid administration in the intervention group (Arm A) - Time from end of suture to extubation - Postoperative nausea and vomiting (PONV) 2h and 22-26h after extubation - Need for antiemetic medication - Postoperative pain (NRS) 2h or 22-26h after extubation - Drop in oxygen saturation (SpO2 < 92%) for longer than 30 seconds or need for oxygen in the post anesthesia care unit - Postoperative pulmonary complications - Postoperative atelectasis and inhomogeneity of pulmonary ventilation - Length of stay in the post anesthesia care unit - Opioid requirements within 24 h after extubation - Quality of Recovery 40-score (QoR-40) - Time to first postoperative bowel movement - Hospital length of stay - Drinking quantity on postoperative day 1 - Postoperative morbidity up to day 30 as measured by the Comprehensive Complication Index (CCI) - Occurrence of defined adverse events intraoperatively - Occurrence of defined adverse events postoperatively

—

Countries

Germany

Contacts

Public ContactSusanne Blank

Universitätsmedizin Mannheim - Chirurgische Klinik

Susanne.Blank@umm.de+49 6213832225

Outcome results

None listed

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