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Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia
NA trial testing 5-8ml 0.375% ropivacaine in Gastric Cancer in 60 participants. Completed in 25 May 2022.
| Lead sponsor | Wang Jiangling |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 November 2021 |
| Primary completion | 25 May 2022 |
| Estimated completion | 25 May 2022 |
| Sites | 1 location across China |
Wang Jiangling — full company profile →
Adults 18 to 75, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recording propofol EC50 for inducing loss of conciousness between general with epidural anesthesia group and general group with propofol effect-site target-controlled infusion (TCI) system
| Group | Value | 95% CI |
|---|---|---|
| Combined Epidural With General Anesthesia | 2.97 | ± 0.44 |
| General Anesthesia | 3.36 | ± 0.22 |
Recording the effect-site concentration of propofol (Ceprop) which showed on target-controlled infusion (TCI) system at loss of consciousness and discontinuation of anesthetics
| Group | Value | 95% CI |
|---|---|---|
| Combined Epidural With General Anesthesia | 2.63 | ± 0.38 |
| General Anesthesia | 1.97 | ± 0.56 |
Recording the total propofol and reminfentanil consumption during surgery
| Group | Value | 95% CI |
|---|---|---|
| Combined Epidural With General Anesthesia | 0.11 | ± 0.02 |
| General Anesthesia | 0.13 | ± 0.02 |
Recording the first postoperative exhaust time by daily follow up
| Group | Value | 95% CI |
|---|---|---|
| Combined Epidural With General Anesthesia | 78.0 | 58.5 – 110.0 |
| General Anesthesia | 85.0 | 76.5 – 104.3 |
The beneficial of perioperative usage of thoracic epidural anesthesia and analgesia in various thoracic and upper abdominal surgery are well studied. However, intraoperative data are lacking whether combined thoracic epidural and general anesthesia have effect on the median (50%) effective effect-concentration (EC50) of propofol for inducing loss of consciousness (LOC). We performed this study among patients undergoing open gastrectomy in gastric cancer patients. Sixty patients undergoing open gastrectomy were randomly assigned to two groups with thoracic combined general anesthesia (TEA+GA) or general anesthesia (GA) alone. Target-controlled infusion (TCI) of propofol was used for anesthesia induction. The initial propofol concentration of target effect-site (Ceprop) was 3.5 ug/ml and was increased stepwise by 0.5ug/ml at each 4 min intervals by an un-down sequential method to reach LOC. The predicted Ceprop at the time of LOC, intravenous anesthetics, vasopressor requirement, emergency time from anesthesia and postoperative numeric rating scale (NRS) were recorded and analyzed between two groups.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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