NCT05716399

Brief Summary

This study is intended to include elderly patients who are selected to undergo lower limb and pelvic orthopedic surgery under spinal anesthesia. Through prospective, randomized and controlled clinical trials, the investigators will observe the effect of this treatment on the incidence of hypotension in elderly patients after spinal anesthesia through TEAS points Neiguan and Quchi before or during surgery, and further explore its related mechanisms.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

January 5, 2023

Last Update Submit

February 6, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension

    30 mins after anesthesia, hypotension was defined as MAP\<25% of the baseline value

    30 mins after anesthesia

Study Arms (3)

Transcutaneous electric stimulation pretreatment group

EXPERIMENTAL

30 minutes before the implementation of spinal anesthesia, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.

Device: Transcutaneous electric stimulation pretreatment

Transcutaneous acupoint electrical stimulation treatment group

ACTIVE COMPARATOR

Within 30 minutes after the occurrence of hypotension, TEAS (density wave 10/50Hz, one side of Neiguan point and Quchi point connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.

Device: Transcutaneous acupoint electrical stimulation treatment

Transcutaneous acupoint pseudo electric stimulation group

SHAM COMPARATOR

Paste the electrode, turn on the power, but no current output.

Device: Transcutaneous acupoint pseudo electric stimulation

Interventions

Transcutaneous electric stimulation pretreatmentDEVICE

Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output.

Transcutaneous electric stimulation pretreatment group
Transcutaneous acupoint electrical stimulation treatmentDEVICE

Transcutaneous acupoint electrical stimulation treatment

Transcutaneous acupoint electrical stimulation treatment group
Transcutaneous acupoint pseudo electric stimulationDEVICE

Transcutaneous acupoint pseudo electric stimulation

Transcutaneous acupoint pseudo electric stimulation group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \>65, regardless of gender;
  • ASA classification I-III; ③ Orthopedic surgery was performed under spinal anesthesia; ④ Sign the informed consent form.

You may not qualify if:

  • Uncontrolled hypertension;
  • Arrhythmia or myocardial ischemia;
  • Severe cardiopulmonary insufficiency;
  • HB\<100g/L;
  • Severe dehydration; ⑥ There are contraindications to spinal anesthesia; ⑦ Allergies to local anesthetics;
  • Communication barriers; ⑨ Refusing to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wenli Wang, Doctor

    Shanghai Tongji Hospital, Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaorui Gu, Doctor

CONTACT

051866111070870005908@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In order to ensure the objectivity and reliability of the study, the statistical analysts are blinded, and the subjects and operators are not blind. The operator is responsible for the implementation of anesthesia, the connection and use of TEAS, and data collection; The statistical analyst is responsible for data entry, data sorting and statistical analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 5, 2023

First Posted

February 8, 2023

Study Start

February 20, 2023

Primary Completion

December 20, 2023

Study Completion

December 30, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share