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Preliminary study on analgesic and sedative effects of percutaneous acupoint electrical stimulation in vertebroplasty in OVCF patients

Phase 1
Conditions
osteoporotic vertebral compression fracture
Registration Number
ITMCTR2200006455
Lead Sponsor
Wangjing Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Meet the diagnostic criteria of OVCF and t9-l5 single segment percutaneous vertebroplasty;
(2) Age 60 to 80 years old;
(3) ASA class I-II;
(4)18kg/m 2 < BMI < 30kg/m 2
(5)Voluntarily participate in this clinical study and sign the informed consent form.

Exclusion Criteria

(1) Taking sedative and analgesic drugs, or taking drugs or drinking alcohol within 48 hours before operation;
(2) Communication disorders, including language disorders, previous nervous system diseases and mental disorders;
(3) Those who have contraindications to transcutaneous electrical stimulation, including those who stimulate local skin damage or infection, have implants in the body
Sexual electrophysiological device;
(4) Allergic to narcotic drugs;
(5) Severe heart, liver, kidney and other organ dysfunction, blood system and autoimmune diseases, acute and slow sex appeal
Infected, malignant tumor or serious mental disease;
(6)Unable to cooperate with the researcher to complete this study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Agitation sedation score;Visual analogue scale of anxiety;Systolic blood pressure (SP), diastolic blood pressure (DP), mean arterial pressure (map), heart rate (HR), blood oxygen saturation (SpO2);Subjective satisfaction score; The number of additional drugs during operation;Bispectral index (BIS);Occurrence of adverse events;Anxiety self rating;VAS score of low back pain;
Secondary Outcome Measures
NameTimeMethod
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