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The Effect of TEAS on the Quality of Early Recovery

Primary Purpose

C.Delivery; Surgery (Previous), Gynecological, Inappropriate Device Stimulation of Tissue, Delayed Emergence From Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TEAS
Con
propofol, remifentanil, vecuronium
mechanical ventilation
Sponsored by
Guizhou Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for C.Delivery; Surgery (Previous), Gynecological focused on measuring Transcutaneous electric acupoint stimulation (TEAS), gynecological laparoscopic surgery, QoQ-40, MMSE, VAS

Eligibility Criteria

29 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    TEAS Group

    Con Group

    Arm Description

    TEAS 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.

    The 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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 20, 2015
    Last Updated
    November 28, 2015
    Sponsor
    Guizhou Provincial People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02619578
    Brief Title
    The Effect of TEAS on the Quality of Early Recovery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guizhou Provincial People's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    C.Delivery; Surgery (Previous), Gynecological, Inappropriate Device Stimulation of Tissue, Delayed Emergence From Anesthesia
    Keywords
    Transcutaneous electric acupoint stimulation (TEAS), gynecological laparoscopic surgery, QoQ-40, MMSE, VAS

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TEAS Group
    Arm Type
    Other
    Arm Description
    TEAS 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.
    Arm Title
    Con Group
    Arm Type
    Other
    Arm Description
    The 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.
    Intervention Type
    Other
    Intervention Name(s)
    TEAS
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Con
    Intervention Description
    The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation.
    Intervention Type
    Drug
    Intervention Name(s)
    propofol, remifentanil, vecuronium
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    mechanical ventilation
    Intervention Description
    Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.
    Primary Outcome Measure Information:
    Title
    Scores on QoR-40
    Description
    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).
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Scores on MMSE
    Description
    mini-mental state examination (MMSE) scores performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
    Time Frame
    1 year
    Title
    Scores on VAS
    Description
    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).
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    The incidence of nausea and vomiting
    Description
    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.
    Time Frame
    1 year
    Title
    The incidence postoperative pain medications
    Description
    The incidence of postoperative pain medications were recorded.
    Time Frame
    1 year
    Title
    The incidence postoperative antiemetics
    Description
    The incidence of antiemetics were also recorded.
    Time Frame
    1 year
    Title
    Age
    Description
    The patients' age were recorded
    Time Frame
    1 year
    Title
    Height
    Description
    The patients' height were recorded
    Time Frame
    1 year
    Title
    Body mass index (BMI)
    Description
    The patients' BMI were recorded
    Time Frame
    1 year
    Title
    ASA physical status
    Description
    ASA physical status of patients were recorded
    Time Frame
    1 year
    Title
    Anesthesia duration and surgery duration
    Description
    Anesthesia duration was recorded
    Time Frame
    1 year
    Title
    Intra-operative fluids
    Description
    Intra-operative fluids was recorded
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    29 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31915045
    Citation
    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.
    Results Reference
    derived

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