Acupoint Stimulation and Postoperative Sleep

NCT ID: NCT04632576

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2024-01-28

Brief Summary

Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.

Detailed Description

Sleep is a necessary, naturally occurring physiologic state that is especially critical to cognition and physical functioning in surgical settings.Poor postoperative sleep is associated with many significant deleterious effects. Therefore, improving overall sleep during postoperative rehabilitation is desirable.

Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive acupuncture therapy combining the transcutaneous electrical nerve stimulation, and has been utilized in clinical settings for many years. Previous study demonstrated that TEAS combined with anesthesia can upregulate the levels of melatonin and aminobutyric acid to relief central inhibition, thus improve patients'sleep efficiency, prolong total sleep time (TST) and promote sleep quality.

The current study is to examine the effect of perioperative TEAS on subjective and objective sleep quality among patients who have undergone Gynecological laparoscopic surgery under general anesthesia.

Conditions

Anesthesia; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

transcutaneous electrical acupoint stimulation

transcutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery.

Group Type: EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type: OTHER

Electrodes will be attached on the surface of acupoints and electrical stimulation will given.

Control

Electrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

transcutaneous electrical acupoint stimulation

Electrodes will be attached on the surface of acupoints and electrical stimulation will given.

Intervention Type: OTHER

Other Intervention Names

TEAS

Eligibility Criteria

Inclusion Criteria

1. Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia

2. Patients aged 18-65 years

3. Patients with a body mass index (BMI) at 18-30kg/m2

4. Patients with American Society of Anesthesiologists (ASA) grades I-III

5. Patients who provide written informed consent

Exclusion Criteria

1. Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))

2. Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3));

3. Participants with central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.

4. Participants with contraindications to the use of electroacupuncture (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices).

5. Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease

6. Participants with a history of alcohol or drug abuse. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Zhihong LU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwest Women's and Children's Hospital

Xi'an, Shaanxi, China

the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, China

The Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Xi 'an Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, China

Countries

China

References

Song B, Chang Y, Li Y, Zhu J. Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial. Nat Sci Sleep. 2020 Oct 27;12:809-819. doi: 10.2147/NSS.S270739. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33154688 (View on PubMed)

Other Identifiers

XJH-A-20220325

Identifier Type: -

Identifier Source: org_study_id