Effect of Acupoint Electrical Stimulation on Incidence of Hypotension After Spinal Anesthesia

Effect of Transcutaneous Electrical Stimulation of Acupoints on the Incidence of Hypotension After Spinal Anesthesia in Elderly Patients Undergoing Orthopaedic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Device: Transcutaneous electric stimulation pretreatment; Device: Transcutaneous acupoint electrical stimulation treatment; Device: Transcutaneous acupoint pseudo electric stimulation

Detailed Description

Research content: This study aims to observe whether TEAS intervention on Neiguan (PC-6) and Quchi (LI-11) before and during operation can improve the incidence and degree of hypotension after spinal anesthesia, as well as the changes of neurotransmitters and related hormones in blood.

Research methods:

• 111 elderly patients (including hip or lower limb fractures, hip and knee joint replacement or debridement) who were selected for lower limb or pelvic surgery under spinal anesthesia were randomly divided into percutaneous point electrical stimulation pretreatment group (PTEAS group), percutaneous point electrical stimulation treatment group (TEAS group) and percutaneous point pseudo electrical stimulation group (FTEAS group).

  • After entering the operating room, the vital signs were monitored routinely, and the volume was evaluated by measuring the variability of the inferior vena cava with ultrasound before anesthesia. Then, the radial artery was punctured and catheterized, and sodium lactate was infused (8ml/Kg).

    • 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.

      • Select L2/3 or L3/4 interval for spinal anesthesia, use 0.75% cloth ratio, and the dose standard is 0.025ml/Kg.

        • Collect venous blood after entering the operating room and 30 minutes after anesthesia to measure the levels of neurotransmitters and hormones, record the baseline value of vital signs and changes during operation, observe the occurrence and treatment of adverse events during operation, and follow up the troponin T level and the incidence of delirium after operation.

          • Remedial measures for clinical safety:

When severe hypotension occurs during operation, which leads to irreversible adverse effects, it needs to be intervened by multiple means.

Those who are diagnosed as delirium through CAM determination shall be treated with haloperidol or dexmedetomidine.

• Study Type: Interventional
• Enrollment (Anticipated): 111
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaorui Gu, Doctor; Phone Number: 051866111070; Email: 870005908@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 90>65, regardless of gender;

  • ASA classification I-III; ③ Orthopedic surgery was performed under spinal anesthesia; ④ Sign the informed consent form.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcutaneous electric stimulation pretreatment group; 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; 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.
ACTIVE_COMPARATOR: Transcutaneous acupoint electrical stimulation treatment group; 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 electrical stimulation treatment
SHAM_COMPARATOR: Transcutaneous acupoint pseudo electric stimulation group; Paste the electrode, turn on the power, but no current output.	Device: Transcutaneous acupoint pseudo electric stimulation; Transcutaneous acupoint pseudo electric stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension	30 mins after anesthesia, hypotension was defined as MAP<25% of the baseline value	30 mins after anesthesia

Collaborators and Investigators

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
• Collaborators: ShuGuang Hospital
• Investigators: Principal Investigator: Wenli Wang, Doctor, Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 20, 2023
• Primary Completion (ANTICIPATED): December 20, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2021-984-59-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No