Investigating the effect of simultaneous infusion of lidocaine and ketamine compared to single infusion of lidocaine and ketamine on neuromonitoring in spine surgeries

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230204057318N2

Enrollment

Registered

2023-07-16

Start date

2023-07-23

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromonitoring status in spine surgeries. Fusion of spine

Interventions

Intervention 1: Intervention group: After general anesthesia in the ketamine group, 0.3 mg/kg/h of ketamine will be administered during the operation and will be stopped at the beginning of skin closu

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Candidate patients for spine surgery under neuromonitoring Age 18 to 65 years Patients with ASA class 1 or 2

Exclusion criteria

Exclusion criteria: Absence of any significant laboratory disturbance in coagulation, kidney, liver function tests, blood cell count No history of drug addiction Insensitivity to ketamine or local anesthetics Absence of contraindications for performing MEP (epilepsy, cerebral cortex damage, increased intracranial pressure, cardiac pacemaker, intracranial electrodes, or vascular clamps)

Design outcomes

Primary

Measure	Time frame
Latency and amplitude changes in neuromonitoring. Timepoint: During surgery. Method of measurement: Analysis of neural wave diagram.	—

Secondary

Measure	Time frame
Intraoperative hemodynamic. Timepoint: During surgery. Method of measurement: Hemodynamic monitoring device.;Intraoperative hemorrhage. Timepoint: During surgery. Method of measurement: Suction bottle and gauzes.;Emergence time from anesthesia. Timepoint: During surgery. Method of measurement: Chronometer.;Pain in the recovery room. Timepoint: Recovery. Method of measurement: Visual Analogue Scale (VAS).;First time of analgesia request. Timepoint: Post surgery. Method of measurement: Watch.;Postoperative nausea and vomiting. Timepoint: Recovery room. Method of measurement: Questionary.;Sedation - agitation status. Timepoint: Recovery room. Method of measurement: Riker Sedation- Agitation Scale.	—

Measure

Time frame

Intraoperative hemodynamic. Timepoint: During surgery. Method of measurement: Hemodynamic monitoring device.;Intraoperative hemorrhage. Timepoint: During surgery. Method of measurement: Suction bottle and gauzes.;Emergence time from anesthesia. Timepoint: During surgery. Method of measurement: Chronometer.;Pain in the recovery room. Timepoint: Recovery. Method of measurement: Visual Analogue Scale (VAS).;First time of analgesia request. Timepoint: Post surgery. Method of measurement: Watch.;Postoperative nausea and vomiting. Timepoint: Recovery room. Method of measurement: Questionary.;Sedation - agitation status. Timepoint: Recovery room. Method of measurement: Riker Sedation- Agitation Scale.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Shakeri

Shahid Beheshti University of Medical Sciences

dr.alirezashakeri@gmail.com+98 21 7343 0000

Outcome results

None listed

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