Lidocaine Infusion With ANI Monitoring in Spine Surgery.

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05103215
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Anticipated Duration (Months): 16.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Spine Surgery	Drug: Lidocaine HCl 2%; Drug: Normal saline	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.
• Anticipated Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.; Other Names: Xylocaine Injection 2%
Placebo Comparator: control group Patients in control group receive the same volume of saline injection.	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.; Other Names: 0.9% Normal Saline (20mL)

Outcome Measures

Primary Outcome Measures

1. cumulative amount of opioids used [within 48 hours after operation]

   cumulative amount of opioids used after the operation

2. the quality of recovery after the operation [on the third day after the operation]

   Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome

3. pain score [within 72 hours after operation]

   numerical rating scale, NRS, 0-10, higher score means worse outcome

Secondary Outcome Measures

1. cumulative amount of opioids used [within 72 hours after operation]

   cumulative amount of opioids used after the operation

2. cumulative amount of propofol used [during operation]

   cumulative amount of propofol used

3. cumulative amount of remifentanil used [during operation]

   cumulative amount of remifentanil used

4. cumulative amount of rocuronium used [during operation]

   cumulative amount of rocuronium used

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Study Chair: Zhi-Fu Wu, MD, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan (R.O.C.)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT05103215
• Other Study ID Numbers: KMUHIRB-F(I)-20210157
• First Posted: Nov 2, 2021
• Last Update Posted: Nov 30, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: Lidocaine, enhanced recovery after surgery
• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of Nov 30, 2021