Super Lizer in venous access

JRCT ID: jRCT1032240250

Registered date:02/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Breast surgery
• Date of first enrollment: 02/08/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1.The venous access site will be on the dorsal hand opposite the surgery side. Since our hospital is a designated clinical training institution, venous access will be handled by junior residents as part of routine clinical practice. The size of the venous cannula will be 20G.
2.Patient conditions will be confirmed, informed consent will be obtained, and the consent form will be signed by the patient by the day before the procedure.
3.On the day of the procedure, EMLA cream (topical lidocaine/prilocaine cream) will be applied to the intended venous access site for more than 15 minutes before entering the room; the patient will be brought to the operating room set at 25 degrees Celsius; randomization will be conducted using REDCap.
4.For patients in the intervention group, stellate ganglion irradiation will be performed on the intended venous access side using a super laser (output 90%, duration 5 minutes).
5.For patients in the control group, the super laser probe will be placed on the stellate ganglion site without output for 5 minutes, and pre-recorded sound of the laser will be played during this time in order to blind the patient.
6.Five minutes after the end of the laser application, venous access will be independently secured by a junior resident with at least one month of anesthesia training who is not a research collaborator. Necessary outcome measurements will be recorded.
7.If the first attempt fails, additional measures such as using an ultrasound device, using nitrous oxide (laughing gas), or changing personnel will be taken to minimize the burden on the patient.

Outcome(s)

• Primary Outcome: The success rate of securing venous access on the first attempt

Secondary Outcome

1.Time taken to successfully secure venous access.
2.Side effects from the laser application (e.g., pain, redness).
3.Measures taken after failure of first attempt at securing venous access (e.g., guidance by a supervising physician, use of nitrous oxide, ultrasound, or change of personnel).
4.Patient satisfaction with venous access:
1)Overall satisfaction (rated on a scale of 0-10, measured immediately after securing venous access).
2)Net Promoter Score (willingness to recommend the procedure to others, rated on a scale of 0-10, measured immediately after securing venous access).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.Adult female patients scheduled for breast surgery.
2.Patients classified as ASA-PS 1-3 according to the American Society of Anesthesiologists Physical Status Classification.
3.Patients for whom venous access can be secured on the dorsal hand opposite the surgery side.

Exclude criteria

1.If consent cannot be obtained.
2.If venous access has already been secured.
3.Patients who have previously undergone super laser treatment.
4.If the attending physician deems participation in the study inappropriate.

Related Information

• Primary Sponsor: Sugiyama Daisuke
• Secondary Sponsor: Jin Zhuan