Clinical trial NCT03912688: TEAS Reduces Remifentanil Consumption
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pain
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: consumption of remifentanil
timeFrame: from start of anesthesia to extubation, on average 2 hours
Secondary outcomes:
measure: time to recall
timeFrame: from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
measure: time to extubation
timeFrame: from end of remifentanil infusion to extubation,approximately 10 minutes on average
measure: respiratory depression
timeFrame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
measure: nausea and vomiting
timeFrame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
measure: visual analogue scale of pain
timeFrame: end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
measure: patients' satisfaction score
timeFrame: from end of surgery to 24 hours after surgery, totally 24 hours
measure: incidence of pain at 3m after surgery
timeFrame: from discharge from hospital to 3 months after surgery, approximately 3 months
measure: incidence of pain at 6m after surgery
timeFrame: from discharge from hospital to 6 months after surgery, approximately 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. doi: 10.1016/0002-9149(74)90207-0. No abstract available.
citation: Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.
citation: Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
citation: Yan B, Li K, Xu J, Wang W, Li K, Liu H, Shan B, Tang X. Acupoint-specific fMRI patterns in human brain. Neurosci Lett. 2005 Aug 5;383(3):236-40. doi: 10.1016/j.neulet.2005.04.021.