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TEAS Reduces Remifentanil Consumption (TRIM)

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ClinicalTrials.gov Identifier: NCT03912688
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zhihong LU, Fourth Military Medical University

Brief Summary:
Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.

Condition or disease Intervention/treatment Phase
Anesthesia Pain Device: acupoint stimulation Device: single acupoint Device: dual acupoints Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Interventions were performed by a designated investigator who was not involved in the anaesthesia or the follow-up. The stimulator was placed in an opaque box to blind the surgical team and the anesthesiologists to the group allocation.
Primary Purpose: Treatment
Official Title: Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single acupoint stimulation Device: acupoint stimulation
Device: single acupoint
Experimental: dual acupoints stimulation Device: acupoint stimulation
Device: dual acupoints
No Intervention: no stimulation



Primary Outcome Measures :
  1. consumption of remifentanil [ Time Frame: from start of anesthesia to extubation, on average 2 hours ]

Secondary Outcome Measures :
  1. time to recall [ Time Frame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average ]
  2. time to extubation [ Time Frame: from end of remifentanil infusion to extubation,approximately 10 minutes on average ]
  3. respiratory depression [ Time Frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes ]
  4. nausea and vomiting [ Time Frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes ]
  5. visual analogue scale of pain [ Time Frame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes ]
    pain intensity is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain

  6. patients' satisfaction score [ Time Frame: from end of surgery to 24 hours after surgery, totally 24 hours ]
    patients' satisfaction score is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain

  7. incidence of pain at 3m after surgery [ Time Frame: from discharge from hospital to 3 months after surgery, approximately 3 months ]
    percentage of patients suffering from pain around the incision

  8. incidence of pain at 6m after surgery [ Time Frame: from discharge from hospital to 6 months after surgery, approximately 3 months ]
    percentage of patients suffering from pain around the incision



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 65 yrs
  • body mass index (BMI) of 18 to 30 kg/m2
  • elective radical mastectomy under general anaesthesia

Exclusion Criteria:

  • contradictions to TEAS
  • difficulties in communication
  • histories of general anaesthesia
  • drug or alcohol abuse or addiction
  • cardiac dysfunction or severe hypertension
  • confirmed hepatic dysfunction and renal impairment
  • the participants recruited into other clinical trials during last three months

Publications of Results:
Other Publications:
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Responsible Party: Zhihong LU, principle investigator, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03912688     History of Changes
Other Study ID Numbers: XJA-S-20190212
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents