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NCT Number: NCT02619578

The Effect of TEAS on the Quality of Early Recovery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

TEAS

Other

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.

CON

Other

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

propofol, remifentanil, vecuronium

Drug

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 ventilation

Other

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

Primary outcomes

  1. Scores on QoR-40

    Time frame: 1 year

    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).

Secondary outcomes

  1. Scores on MMSE

    Time frame: 1 year

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

  2. Scores on VAS

    Time frame: 1 year

    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).

Other outcomes

  1. The incidence of nausea and vomiting

    Time frame: 1 year

    The incidence of nausea and vomiting were also recorded.Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; vomiting was defined as the forceful expulsion of gastric contents from the mouth brought about by the powerful sustained contraction of abdominal muscles.

  2. The incidence postoperative pain medications

    Time frame: 1 year

    The incidence of postoperative pain medications were recorded.

  3. The incidence postoperative antiemetics

    Time frame: 1 year

    The incidence of antiemetics were also recorded.

  4. Age

    Time frame: 1 year

    The patients' age were recorded

  5. Height

    Time frame: 1 year

    The patients' height were recorded

  6. Body mass index (BMI)

    Time frame: 1 year

    The patients' BMI were recorded

  7. ASA physical status

    Time frame: 1 year

    ASA physical status of patients were recorded

  8. Anesthesia duration and surgery duration

    Time frame: 1 year

    Anesthesia duration was recorded

  9. Intra-operative fluids

    Time frame: 1 year

    Intra-operative fluids was recorded

Sponsors and collaborators

Lead sponsor

Guizhou Provincial People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2015
Registry last updated
Dec 2, 2015

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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