Clinical trial NCT02597530: Different Stimuli of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia
Official title: Effect of Different Time of Transcutaneous Electric Acupoint Stimulation(TEAS) on Acupuncture Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Keywords: TEAS
anesthesia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases by Jingluo (the system of meridians, through which energy is thought to ﬂow through the body in Chinese medicine). It is usually applied to relieve pain. Several clinical trials have been conducted to evaluate the effect of electroacupuncture on the consumption of intra-operative anaesthetics and on drug-related side-effects, with promising results. Compared with acupuncture or electroacupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique and has some advantages, including no risk of infections or needle-induced contagious disease and reduced fear of stimulation. It can potentially be applied by any anaesthetist or pre-operative personnel with minimal training.Thus, investigators conducted this controlled, prospective, double-blinded clinical trial to investigate whether treating by transcutaneous electrical acupoint stimulation combined with general anesthetic during peri-operative could alleviate the dosage of anesthetic drugs compared with control and sham group.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Consumption of remifentanil during the operation（ug/kg/min）.
timeFrame: intraoperative
Secondary outcomes:
measure: Content of endocrine hormone in the blood(angiotensin-II(ng/L),Cortisol(nmol/L),β-endorphin(ng/mL) and glucose(mmol/L)).
timeFrame: intraoperative
measure: Time of extubation after operation.
timeFrame: intraoperative
measure: Pain after the operation(visual analog scale (vas)).
timeFrame: 0 hours ,2 hours ,12 hours ,24 hours after operation
measure: Side-effects of anesthetics(nausea,vomiting,dizziness and pruritus).
timeFrame: 0 hours ,2 hours ,12 hours ,24 hours after operation
measure: Hospital stays after operation(d).
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Qiang x Qiang Wang
role: STUDY_CHAIR
References:
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: 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.
citation: 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.
citation: 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.
citation: 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.