Different Stimuli of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia

NCT02597530 | Unknown

• 2 other identifiers: Xijingmazuimazuike
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Conditions

Acupuncture

Keywords

TEAS; anesthesia

Outcome Measures

Primary Outcomes (1)

• Consumption of remifentanil during the operation（ug/kg/min）.

  intraoperative

Secondary Outcomes (5)

• Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).

  intraoperative

• Time of extubation after operation.

  intraoperative

• Pain after the operation(visual analog scale (vas)).

  0 hours ,2 hours ,12 hours ,24 hours after operation

• Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).

  0 hours ,2 hours ,12 hours ,24 hours after operation

• Hospital stays after operation(d).

  Participants will be followed for the duration of hospital stay, an expected average of 4 days

Study Arms (3)

Long-term stimulution group

EXPERIMENTAL

According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.Patients in Long-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and continued until the end of the surgery with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over.

Device: TEAS

Short-term stimulution group

OTHER

According to ancient Chinese medical books, acupoints Hegu and Zusanli are chosen and identified.The patients in Short-term stimulation group received electrical stimulation with the 'disperse-dense' waves.TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia with dilatational wave(2-15HZ).All patients will remove electrodes on surgery over.

Device: TEAS

Sham group

PLACEBO COMPARATOR

Patients in sham group will be pasted electrodes 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.

Device: TEAS

Interventions

TEAS DEVICE

According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.

Long-term stimulution group; Sham group; Short-term stimulution group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65
• ASA physical statusⅠorⅡ
• Elective gynecological laparoscopic surgery under general anesthesia
• BMI of 18 to 25
• Duration of operation≤2 hours
• Patient who signed the informed consent

You may not qualify if:

• Pregnancy or breast-feeding women
• Serious lung disease/Serious cardiovascular disease/Serious liver, renal abnormalities
• Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease
• Patient has diseases in nervous-mental system
• Operation time more than 2 hours
• Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints;
• Patients with experience of transcutaneous electrical stimulation treatment.

Sponsors & Collaborators

• wangqiang: lead

Related Publications (5)

• 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.

  PMID: 24576720 BACKGROUND

• Iacobone M, Citton M, Zanella S, Scarpa M, Pagura G, Tropea S, Galligioni H, Ceccherelli F, Feltracco P, Viel G, Nitti D. The effects of acupuncture after thyroid surgery: A randomized, controlled trial. Surgery. 2014 Dec;156(6):1605-12; discussion 1612-3. doi: 10.1016/j.surg.2014.08.062. Epub 2014 Nov 11.

  PMID: 25456960 BACKGROUND

• Lee MS, Ernst E. Acupuncture for surgical conditions: an overview of systematic reviews. Int J Clin Pract. 2014 Jun;68(6):783-9. doi: 10.1111/ijcp.12372. Epub 2014 Jan 22.

  PMID: 24447388 BACKGROUND

• Sahni N, Anand LK, Gombar K, Gombar S. Effect of intraoperative depth of anesthesia on postoperative pain and analgesic requirement: A randomized prospective observer blinded study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):500-5. doi: 10.4103/0970-9185.86595.

  PMID: 22096284 BACKGROUND

• Han JS. Acupuncture analgesia: areas of consensus and controversy. Pain. 2011 Mar;152(3 Suppl):S41-S48. doi: 10.1016/j.pain.2010.10.012. No abstract available.

  PMID: 21078546 BACKGROUND

Study Officials

• Qiang x Qiang Wang

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Shan He

CONTACT

15129014406; 986994820@qq.com

Qiang Wang

CONTACT

86-29-84775343; dr.wangqiang@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 11, 2015

Record last verified: 2015-12