Lidocaine Infusion With ANI Monitoring in Spine Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2025-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lidocaine group

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.

Group Type EXPERIMENTAL

Lidocaine HCl 2%

Intervention Type 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.

control group

Patients in control group receive the same volume of saline injection.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type 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.

Interventions

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Lidocaine HCl 2%

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.

Intervention Type DRUG

Normal saline

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.

Intervention Type DRUG

Other Intervention Names

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Xylocaine Injection 2% 0.9% Normal Saline (20mL)

Eligibility Criteria

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Inclusion Criteria

1. Twenty to eighty-year-old
2. ASA class I-III patients undergoing
3. Elective lumbar spine surgery under general anesthesia

Exclusion Criteria

1. Unable to understand the Numerical Rating Scale (NRS)
2. Severe mental disorder
3. Poor liver function
4. Pregnant or lactating women
5. Morbidly obese
6. History of epilepsy or allergy to any of the drugs used in this study
7. Current use of opioids
8. Baseline heart rate \<50 beats/min
9. Arrhythmia history with cardiac rhythm device
10. Body weight \<40 kg and \>80kg

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No