TEAS Reduces Remifentanil Consumption

Pain Clinical Trial

— TRIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912688
• Other study ID #: XJA-S-20190212
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Device:
• acupoint stimulation

• single acupoint

• dual acupoints

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

References & Publications (4)

Kuhn LA. Editorial: Acupuncture anesthesia for open heart surgery. Am J Cardiol. 1974 Aug;34(2):254-5. — View 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. Review. — View 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 pr — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of remifentanil		from start of anesthesia to extubation, on average 2 hours
Secondary	time to recall		from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average
Secondary	time to extubation		from end of remifentanil infusion to extubation,approximately 10 minutes on average
Secondary	respiratory depression		end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
Secondary	nausea and vomiting		end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
Secondary	visual analogue scale of pain	pain intensity is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain	end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes
Secondary	patients' satisfaction score	patients' satisfaction score is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain	from end of surgery to 24 hours after surgery, totally 24 hours
Secondary	incidence of pain at 3m after surgery	percentage of patients suffering from pain around the incision	from discharge from hospital to 3 months after surgery, approximately 3 months
Secondary	incidence of pain at 6m after surgery	percentage of patients suffering from pain around the incision	from discharge from hospital to 6 months after surgery, approximately 3 months