Acupoint Stimulation and Postoperative Sleep

NCT04632576 | Completed DMC

• 1 other identifier: XJH-A-20220325
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 4

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.

Conditions

Anesthesia; Sleep

Keywords

anesthetics; sleep; surgery

Outcome Measures

Primary Outcomes (1)

• total sleeping time during the first postoperative night

  The primary outcome is the total sleep time on the first postoperative night according to the sleep diary monitored by actigraphy.

  the first postoperative night

Secondary Outcomes (11)

• Total sleep time during the first 24h after surgery

  from discharge from post-anesthesia care unit to 24hours later, totally 24 hours

• the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery

  the 1 month before hospitalization

• The Athens Insomnia Scale (AIS) score

  from discharge from post-anesthesia care unit to 24hours later, totally 24 hours

• the Epworth Sleepiness Scale (ESS) score

  from discharge from post-anesthesia care unit to 24hours later, totally 24 hours

• the 15-item Quality of Recovery Scale (QoR-15) score

  from discharge from post-anesthesia care unit to 24hours later, totally 24 hours

Study Arms (2)

transcutaneous electrical acupoint stimulation

EXPERIMENTAL

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.

Other: transcutaneous electrical acupoint stimulation

Control

NO INTERVENTION

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.

Interventions

transcutaneous electrical acupoint stimulation OTHER

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

Also known as: TEAS

transcutaneous electrical acupoint stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia
• Patients aged 18-65 years
• Patients with a body mass index (BMI) at 18-30kg/m2
• Patients with American Society of Anesthesiologists (ASA) grades I-III
• Patients who provide written informed consent

You may not qualify if:

• Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
• Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3));
• Participants with central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.
• 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).
• Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease
• Participants with a history of alcohol or drug abuse. Pregnant or lactating women.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (4)

Northwest Women's and Children's Hospital

Xi'an, Shaanxi, China

Location

the First Affiliated Hospital of the Air Force Military Medical University

Xi'an, Shaanxi, China

Location

The Second Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Location

Xi 'an Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, China

Location

Related Publications (1)

• 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.

  PMID: 33154688 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 17, 2020
• Study Start: June 2, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 28, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: during 3 months and 5 years following article publication after deidentification

Locations

CN (4)