A randomized, controlled, open trial confirming the effectiveness of controlling individual opioid needs during balanced general anesthesia using spontaneous breathing

A randomized, controlled, open trial confirming the effectiveness of controlling individual opioid needs during balanced general anesthesia using spontaneous breathing - SpontOP-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020284

Enrollment

Registered

2020-01-29

Start date

2020-02-03

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

Vascular surgery without muscle relaxation

Interventions

Group 1: - balances general anesthesia using Sevoflurane and Remifentanil - when the TOF reaches at least 0,9 spontaneous breathing is possible, so the Remifentanil dose is lowered to 0,1µg/kgIBW/min,

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - men and women over 18 years old - patients who receive general anaesthesia without muscle relaxation (<50% of anaesthesia time) for vascular surgery - ASA 1-3

Exclusion criteria

Exclusion criteria: - patients under 18 years old - lack of information or agreement - additional use of epidural analgesia or regional anesthesia procedure - pregnancy/lactation periode - BMI>35kg/m2 - uncontrolled preoperative hypo- or hypertension (mean arterial pressure 100 mmHg) - preoperative heart rate 100/min - central nervous system disorder - illicit substance or alcohol abuse within 30 days - chronic use of pain medication (opioids) within 30 days - significant medical condition a) untreated or persistent peripheral or central cardiovascular disease b) severe pulmonary disease (e.g. COPD gold 4 , FEV50mmHg) c) significant hepatic disease (CHILD C) d) significant kidney disease which requires dialysis - simultaneous participation in another study - severe PONV (postoperative nausea and vomiting) in anamnesis is required - intolerance to sevoflurane (e.g. malignant hyperthermia or muscle disease) or remifentanil

Design outcomes

Primary

Measure	Time frame
Opioid consumption (absolute and mean value)	—

Secondary

Measure	Time frame
- appearance and number of inadequate anesthesia events - assimilable postoperative sensation of pain (in the recovery room and during the following 24h) - appearance of nausea and emesis - recovery room: time to Aldrete Score >9 and time to Vital Pflege Check grün (recovery room length of stay) - appearance of awareness - wake-up and extubation time - SpO2 in target range (SpO2>94%) - PEEP, ventilation pressure difference, ventilation peak pressure, respiratory rate, etCO2 - number of Propofol-Boluses - blood pressure and heart rate during anesthesia	—

Measure

Time frame

- appearance and number of inadequate anesthesia events - assimilable postoperative sensation of pain (in the recovery room and during the following 24h) - appearance of nausea and emesis - recovery room: time to Aldrete Score >9 and time to Vital Pflege Check grün (recovery room length of stay) - appearance of awareness - wake-up and extubation time - SpO2 in target range (SpO2>94%) - PEEP, ventilation pressure difference, ventilation peak pressure, respiratory rate, etCO2 - number of Propofol-Boluses - blood pressure and heart rate during anesthesia

—

Countries

Germany

Contacts

Public ContactMartin Bellgardt

Katholisches Klinikum Bochum gGmbH

martin.bellgardt@rub.de+492345096700

Outcome results

None listed

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