AnesthesiaASISNCT04632576
Acupoint Stimulation and Postoperative Sleep
A study testing transcutaneous electrical acupoint stimulation in people with Anesthesia and Sleep, run by Air Force Military Medical University, China at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia, Sleep
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 4 sitesChina
- Study dates
- 2 Jun 2023to 28 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Northwest Women's and Children's Hospital
Xi'an, Shaanxi
the First Affiliated Hospital of the Air Force Military Medical University
Xi'an, Shaanxi
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Xi 'an Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery
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.
Read the 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
- Being tested
- transcutaneous electrical acupoint stimulation
- Keywords
- anesthetics, sleep, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationOther
Also called TEAS
Electrodes will be attached on the surface of acupoints and electrical stimulation will given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the first postoperative night
Secondary outcomes (11)
Total sleep time during the first 24h after surgery
total sleep time recorded on the actigraphy on the first perioperative night
Measured: 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 PSQI is used to indicate the sleep quality in the last 1 month.
Measured: the 1 month before hospitalization
The Athens Insomnia Scale (AIS) score
The highest score on the Athens Scale is 24, while the lowest score is 0. The higher the score, the more serious the sleep disorder
Measured: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the Epworth Sleepiness Scale (ESS) score
ESS scores range from 0 to 24, with higher scores indicating higher levels of sleepiness
Measured: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the 15-item Quality of Recovery Scale (QoR-15) score
The QoR-15 score ranges from 0 to 150, and the higher the score, the better the postoperative recovery
Measured: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
Total intraoperative propofol dosage
the total dosage used for the anesthetic induction and maintenance
Measured: From the time of anesthetic induction to the end of the surgery
Times for the needs of rescue analgesics
Times for the needs of rescue analgesics in the first 24h.
Measured: from discharge from operation room to 24 hours later, totally 24 hours
Number of episodes of postoperative adverse events
Number of episodes of postoperative adverse events such as nausea and vomiting, delirium, pulmonary edema, septic shock, arrhythmia, etc after surgery.
Measured: from discharge from the operation room to 48 hours later, totally 48 hours
time of intestinal recovery after surgery
time to first flatus, time to food intake, catheter remove and ambulation
Measured: from discharge from the operation room to 48 hours later, totally 48 hours
length of postoperative hospital stay
length of postoperative hospital stay
Measured: from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days
total wake time during the first 24h after surgery
recorded on the actigraphy on the first perioperative night
Measured: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start2 Jun 2023
- Primary completion23 Jan 2024
- Study completion28 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632576
- Sponsor's protocol ID
- XJH-A-20220325
- Acronym
- ASIS
- Status last verified
- Apr 2024
- First submitted
- 11 Nov 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification.
Publications
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.
PubMed 33154688
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04632576
- Acronym / sponsor ID
- ASIS / XJH-A-20220325
- Conditions
- Anesthesia, Sleep
- Keywords
- anesthetics, sleep, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 28 Jan 2024 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical acupoint stimulation | Experimental | Other: transcutaneous electrical acupoint stimulationtranscutaneous 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical acupoint stimulationAlso: TEASElectrodes will be attached on the surface of acupoints and electrical stimulation will given. | Other | transcutaneous electrical acupoint stimulation |
Primary outcome
total sleeping time during the first postoperative night
Time frame: 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.
11 secondary outcomes
Total sleep time during the first 24h after surgery
Time frame: 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
Time frame: the 1 month before hospitalization
The Athens Insomnia Scale (AIS) score
Time frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the Epworth Sleepiness Scale (ESS) score
Time frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the 15-item Quality of Recovery Scale (QoR-15) score
Time frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
Total intraoperative propofol dosage
Time frame: From the time of anesthetic induction to the end of the surgery
Times for the needs of rescue analgesics
Time frame: from discharge from operation room to 24 hours later, totally 24 hours
Number of episodes of postoperative adverse events
Time frame: from discharge from the operation room to 48 hours later, totally 48 hours
time of intestinal recovery after surgery
Time frame: from discharge from the operation room to 48 hours later, totally 48 hours
length of postoperative hospital stay
Time frame: from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days
total wake time during the first 24h after surgery
Time frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 33154688Song 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.
- Individual participant dataSharing planned: Yes. Individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Anesthesia and Sleep, run by Air Force Military Medical University, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total sleeping time during the first postoperative night (time frame: the first postoperative night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.