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To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).
The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine group | Experimental | Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. |
|
| control group | Placebo Comparator | Patients in control group receive the same volume of saline injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine HCl 2% | Drug | Intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative amount of opioids used | cumulative amount of opioids used after the operation | within 48 hours after operation |
| the quality of recovery after the operation | Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome | on the third day after the operation |
| pain score | numerical rating scale, NRS, 0-10, higher score means worse outcome | within 72 hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative amount of opioids used | cumulative amount of opioids used after the operation | within 72 hours after operation |
| cumulative amount of propofol used | cumulative amount of propofol used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi-Fu Wu, MD | Contact | 07-3121101 | 7035 | aneswu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Fu Wu, MD | Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan (R.O.C.) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | Taiwan |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal saline | Drug | Intravenous injection of 1.5 mg/kg normal saline at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. |
|
|
| during operation |
| cumulative amount of remifentanil used | cumulative amount of remifentanil used | during operation |
| cumulative amount of rocuronium used | cumulative amount of rocuronium used | during operation |