Fluorescence Imaging With Indocyanine Green(ICG) in Endoscopic Spinal Surgery
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration
is time-consuming and critical. According to statistics, the incidence of nerve root injury
under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory
retardation and motor weakness, thereby impairing the physical function of patients. A
real-time auxiliary intraoperative nerve identification technology is necessary.
In this prospective, open-label, randomized, parallel controlled trial, 40 patients who
undergo endoscopic spinal surgery are included. Subjects are randomly divided into control
group and low, medium and high Indocyanine green(ICG) preoperative administration
experimental group. Standard endoscopic spinal surgery is performed in the control group.
Patients in the experimental group received an intravenous injection of ICG before surgery,
and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic
endoscopic surgical imaging system to assist the surgeon in identifying and protecting the
nerve roots.
The main objectives of this experiment are (i) to explore the safety and feasibility of ICG
fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery
and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The
secondary objective is to explore the optimal ICG dosing regimen.