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Completed

NCT Number: NCT03912688

TEAS Reduces Remifentanil Consumption

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.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

acupoint stimulation

Device

single acupoint

Device

dual acupoints

Device

Primary outcomes

  1. consumption of remifentanil

    Time frame: from start of anesthesia to extubation, on average 2 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy

Acronym: TRIM

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 11, 2019
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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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