Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients With Gastrointestinal Tumor (TEAS)

S

Subei People's Hospital of Jiangsu Province

Status

Not yet enrolling

Conditions

Postoperative Cognitive Dysfunction

Treatments

Other: Transcutaneous acupoint electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05482477
Lujuan Xi

Details and patient eligibility

About

Postoperative cognitive dysfunction(POCD). is a central nervous system complication in cancer patients with a 8.9-46.1% incidence. It is mainly manifested as impaired memory, descending information handling ability and decline or damage of attention, perception, abstract thinking, executive, language, and body movement. However, it is difficult to identify and it can last for months or years or even become a dementia state, which can severely affect patients' postoperative recovery, prolong the hospitalization time, reduce the quality of life, increase the mortality and the consumption of family and social medical resources, and intensifies the national economic and social burden. Transcutaneous electrical acupoint stimulation (TEAS) is a new type of acupoint stimulation therapy that inputs low-frequency pulse current into human acupoints through electrodes pasted on the skin surface to achieve therapeutic purposes, which combined the preponderances of both acupuncture and transcutaneous electrical nerve stimulation (TENS). TEAS is non-invasive, easy to operate and acceptable to patients. Study showed that TEAS treatment can reduce the consumption of intraoperative anesthetic and improve postoperative nausea and vomiting (PONV) and postoperative recovery. Also, studies have shown that TEAS treatment may improve the cognitive function of geriatric patients. Most studies have shown that TEAS treatment 10~30 minutes before operation or from entering the operating room to the end of operation can reduce the incidence of POCD in elderly patients. Some studies showed that preoperative combined with postoperative or simple postoperative TEAS treatment can significantly improve patients' postoperative cognitive function. Our previous research showed that perioperative TEAS treatment can reduce the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor. Moreover, studies showed that long-term electroacupuncture treatment is easy to cause "tolerance effect', leading to the activation of the negative feedback mechanism of the body, and reduction of the number of receptors, and the weakening of the treatment effect. So, what is the best time period for TEAS to improve POCD and reduce the use of resources? Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.

Full description

Therefore, the objective of this study is to discuss different time of TEAS on POCD in geriatric patients with gastrointestinal tumor.

Enrollment

238 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 60 years or older.

Patients diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia in Subei People's Hospital of Jiangsu province.

Patients willing and able to give informed consent and comply with this study protocol.

American Society of Anesthesiology (ASA) classification I~III. ⑤ Preoperative Tilburg frailty scale score is less than 5 points. ⑥ Preoperative D-dimer was normal.

Exclusion criteria

Preoperative cognitive dysfunction or history of cognitive dysfunction, dementia, and delirium.

History of severe depression, schizophrenia, or other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past.

Patients with severe hearing or visual impairment without assistive tools.

Patients who have difficulty in communicating.

Male patients average daily pure alcohol intake ≥ 61 g or female patients average daily pure alcohol intake ≥ 41 g.

Patients received surgical treatment within 3 months or preoperative hospitalized over 3 months.

Patients with severe heart, liver, or renal failure.

⑧ Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 min during the operation.

⑨ Patients admitted to ICU after operation.

⑩ Patients who quit or died due to noncooperation or sudden situation.

⑪ Patients who already participate in other clinical studies which may influence this study.

⑫ Patients who underwent emergency surgery.

⑬ Patients who had a history of acupuncture treatment.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

238 participants in 7 patient groups

preoperative TEAS group
Experimental group
Description:
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before anesthesia.
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Intraoperative TEAS group
Experimental group
Description:
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 30 min before anesthesia to the end of surgery
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Postoperative TEAS group
Experimental group
Description:
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, once a day, 30 minutes each time for 7 consecutive days after operation
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Pre-and post-operative TEAS group
Experimental group
Description:
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, from 1 day before operation to 7 days after operation, once a day, 30 minutes each time.
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Perioperative TEAS group
Experimental group
Description:
Receive a TEAS on bilateral Neiguan (PC6) Yintang (GV29) and Zusanli (ST36) by the transcutaneous electrical stimulators to provide an altered frequency 2/100 Hz, disperse-dense waves, and adjusted intensity which was less than 10 mA, 30 min before the induction of anesthesia to the end of the surgery, 1 day before operation, and on the 1st, 2nd and 3rd days after surgery, 30 min once a day.
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Sham TEAS group
Sham Comparator group
Description:
the electrodes were placed at the same time as the perioperative TEAS group, but the electronic stimulation was not applied and they were told that the TEAS treatment have no feeling
Treatment:
Other: Transcutaneous acupoint electrical stimulation
Control group
No Intervention group
Description:
receive standardised perioperative management such as preoperative health education, optimize anaesthesia scheme, intraoperative heat preservation, and reduce surgical trauma.

Trial contacts and locations

0

Loading...

Central trial contact

Daorong Wang Department Director, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems