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Trial Title:
Timing of Transcutaneous Acupoint Electrical Stimulation on Postoperative Recovery in Geriatric Patients with Gastrointestinal Tumor
NCT ID:
NCT05482477
Condition:
Postoperative Cognitive Dysfunction
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Postoperative Cognitive Complications
Cognitive Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Transcutaneous acupoint electrical stimulation
Description:
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.
Arm group label:
Intraoperative TEAS group
Arm group label:
Perioperative TEAS group
Arm group label:
Postoperative TEAS group
Arm group label:
Pre-and post-operative TEAS group
Arm group label:
Sham TEAS group
Arm group label:
preoperative TEAS group
Summary:
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.
Detailed description:
Therefore, the objective of this study is to discuss different time of TEAS on POCD in
geriatric patients with gastrointestinal tumor.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225001
Country:
China
Contact:
Last name:
Liqun - Shi, -
Phone:
0514-87373694
Email:
sbyy112012@163.com
Start date:
January 1, 2025
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Subei People's Hospital of Jiangsu Province
Agency class:
Other
Source:
Subei People's Hospital of Jiangsu Province
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05482477
