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C.Delivery; Surgery (Previous), GynecologicalNCT02619578

The Effect of TEAS on the Quality of Early Recovery

A study testing TEAS, Con and propofol, remifentanil, vecuronium in people with C.Delivery; Surgery (Previous), Gynecological and Inappropriate Device Stimulation of Tissue, run by Guizhou Provincial People's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. Read more about this study

Who is it for?
Ages 29 to 60 years, women onlyHealthy volunteers can take part
What is being tested?
TEAS, Con and propofol, remifentanil, vecuronium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Nov 2013to Nov 2014
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 29 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients undergoing elective gynecological laparoscopic surgery.
  • ASA physical status of I-II.
  • Ages ranged from 29-60 yr.

Who cannot join

  • Recent use of TEAS or acupuncture.
  • Neural damage or infection along the meridian at which the acupoints lay.
  • Use of antiemetic in the previous week.
  • Regular use of opioids.
  • Hepatic dysfunction.
  • Confirmed renal impairment. Diabetes mellitus Cognitive dysfunction Conversion to laparotomy during gynecologic laparoscopy.

About this study

Official title: The Effect of Transcutaneous Electric Acupoint Stimulation on the Quality of Early Recovery in Patients Undergoing Gynecological Laparoscopic Surgery: a Prospective, Randomized, Placebo-controlled Trial

During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia, which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the concentration of plasma catecholamines, cortisol and vasopressin , these responses have an important impact on patient recovery after surgery.

Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on acupuncture, has been widely accepted and used worldwide. To date, multiple studies have demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function. However, whether TEAS could improve the quality of early recovery after gynecologic laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the quality of early recovery in the patients undergoing gynecological laparoscopic surgery.

Read the detailed description

Patient population Sixty patients undergoing elective gynecological laparoscopic surgery at Guizhou province people's hospital with an ASA physical status of I-II were recruited between November 2013 and November 2014. Their ages ranged from 29-60 yr. Exclusion criteria were recent use of TEAS or acupuncture, neural damage or infection along the meridian at which the acupoints lay, use of antiemetic in the previous week, regular use of opioids, hepatic dysfunction, confirmed renal impairment, diabetes mellitus, cognitive dysfunction and conversion to laparotomy during gynecologic laparoscopy.

Randomization and blinding Patients were assigned to either TEAS stimulus (TEAS group) or control group (Con group) on the basis of random numbers generated by a computer. Only the acupuncturist was informed the randomization allocation, just before the onset of TEAS. None of the anesthesiologists, surgeons, physicians in the post-anesthesia care unit (PACU), or participants were aware of the allocation. Blinding of the patients was ensured by using gel electrodes in the same therapeutic setting, which has previously been proved to be a successful strategy.

TEAS protocol An experienced acupuncturist performed TEAS for 30 min before anesthesia. According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization. Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation. The patients in the control group had the electrodes applied but received no stimulation.

Anesthesia and perioperative management One surgeon conducted all surgeries according to a standard protocol; surgery commenced between 8:30 and 1:00 p.m. Anesthesia was induced i.v. with propofol and remifentanil using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v., and patients were orotracheally intubed 5 min later. Anesthesia was maintained with TCI of propofol and remifentanil. The depth of anesthesia was monitored using index (BIS). Effect site concentrations of propofol and remifentanil were adjusted to the hemodynamic and BIS. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. In both groups, remifentanil and propofol infusions were stopped 5 min before the end of surgery. Patients were extubated and transferred to the PACU after surgery.

Data collection Baseline data included demographics, body mass index (BMI), and ASA physical status. Surgical information recorded included anesthesia duration, surgery duration, estimated blood loss, and all other intraoperative medications. Postoperative data were collected regarding the incidence of nausea and vomiting, postoperative pain medications and antiemetics.

The Quality of Recovery-40 (QoR-40) is a validated scale with 5 domains 10-12. These measure physical comfort, emotional state, physical independence, psychological support, and pain. Each domain is scored to a maximum global score of 200. QoR-40 scores have been found to be associated with both quality-of-life scales and patient satisfaction indices 13 as well as postoperative pain 14. In the present study, QoR-40 evaluation was performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

Visual analog scales (VAS) are widely used in behavioral science and previous studies reported their usefulness and validity 15, 16. VAS scores at rest queried about their level of pain on postoperative day 1 (T1) and postoperative day 2 (T2).

The Mini-Mental State Examination (MMSE) is one of the most widely used assessment instruments of cognitive functioning postoperatively, which screens domains of orientation to time and place, attention and memory, concentration, language and praxis 17. Patient cognitive function was assessed using the MMSE on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

Statistical analysis All statistical analyses were performed using SPSS 13.0 (SPSS, Inc., Chicago, IL, USA). Continuous variables are presented as mean (SD) and compared using the unpaired Student's-test. Dichotomus variables were presented as the number of patients (percent) and analyzed using the X2 test. The level of significance for all statistical tests was set at 0.05.

Being tested
TEAS, Con, propofol, remifentanil, vecuronium, mechanical ventilation
Keywords
Transcutaneous electric acupoint stimulation (TEAS), gynecological laparoscopic surgery, QoQ-40, MMSE, VAS
Medical subject headings
Delayed Emergence from Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEASOther

    According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization . Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation.

  • ConOther

    The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation.

  • propofol, remifentanil, vecuroniumDrug

    Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v.

  • mechanical ventilationOther

    Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.

Study groups in NCT02619578
Study groupRoleWhat they receive
TEAS GroupOtherTEAS consisted of 30 min of stimulation (12-15 mA, 2/100 Hz) at the Hegu (L14) and Neiguan (PC6) before anesthesia. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.
Receives: Other: TEAS; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation
Con GroupOtherThe patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.
Receives: Other: Con; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scores on QoR-40

    Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

    Measured: 1 year

Secondary outcomes (2)
  1. Scores on MMSE

    mini-mental state examination (MMSE) scores performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

    Measured: 1 year

  2. Scores on VAS

    A 100-mm visual analogue scale (VAS) scores at rest performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2014
  4. Study completionNov 2014

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619578
Sponsor's protocol ID
A14-30323
Status last verified
Nov 2015
First submitted
20 Nov 2015
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Yu X, Zhang F, Chen B. The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial. Trials. 2020 Jan 8;21(1):43. doi: 10.1186/s13063-019-3892-4.

    PubMed 31915045

Questions about this trial

What is this clinical trial studying?

A study testing TEAS, Con and propofol, remifentanil, vecuronium in people with C.Delivery; Surgery (Previous), Gynecological and Inappropriate Device Stimulation of Tissue, run by Guizhou Provincial People's Hospital.

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 3 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Scores on QoR-40 (time frame: 1 year). 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 NCT02619578, 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 2 Dec 2015.

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