TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery

Study Overview
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Brief Summary
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This study is to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.

Detailed Description
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During robotic laparoscopic gynecologic surgery, the patients are put in an extremely trendelenburg positon. And a long duration of this position could lead to delayed emergence or agitation. Stimulation at some acupoints were reported to improve homeostasis. In this study we tend to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.

Official Title
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Effect of Transcutaneous Electrical Acupoint Stimulation on Outcome During Emergence From Anesthesia in Patients Undergoing Robotic Laparoscopic Gynecologic Surgery

Conditions
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Anesthesia

Intervention / Treatment
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* Other: acupoint stimulation
* Other: non-acupoint stimulation
* Other: electrode attached
* Device: electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia Patients with written informed consent Exclusion Criteria: Patients with difficulty in communication Patients with disease of central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupoint stimulation<br>Electrical stimulation is given through electrodes attached to acupoints | Other: acupoint stimulation<br>* stimulation is given at acupoints<br>Other: electrode attached<br>* electrodes are attached to skin<br>* Other names: electrode;Device: electrical stimulation<br>* electrical stimulation is given through electrodes attached to th skin<br>|
| Placebo Comparator: Non-acupoint stimulation<br>Electrical stimulation is given through electrodes attached to non-acupoints | Other: non-acupoint stimulation<br>* stimulation is given at acupoints<br>Other: electrode attached<br>* electrodes are attached to skin<br>* Other names: electrode;Device: electrical stimulation<br>* electrical stimulation is given through electrodes attached to th skin<br>|
| Sham Comparator: Control stimulation<br>Electrode attached but no stimulation is given | Other: electrode attached<br>* electrodes are attached to skin<br>* Other names: electrode;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to awake | time to open eyes to verbal command | from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Score | status of the patients during emergence | from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour | 
| Time to extubation |  | from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour | 
| QoR-15 | Score of quality of recovery using a 15 items questionaire | from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour | 
| residual sedation |  | from arriving at PACU to departing from PACU,an anticipated average of 30min | 
| PONV | postoperative nausea and vomiting in the PACU | from arriving at PACU to departing from PACU,an anticipated average of 30min | 
| VAS score | visual analogue score of pain in the PACU, scored 0-10 | from arriving at PACU to departing from PACU,an anticipated average of 30min | 
| serum Aquaporin 4 | level of serum Aquaporin 4 before anesthesia and at the end of the surgery | from before anesthesia to after surgery, an anticipated average of 4 hours | 
| serum MMP9 | level of serum Matrix metallop roteinase before anesthesia and at the end of the surgery | from before anesthesia to after surgery, an anticipated average of 4 hours | 
| serum S100β | level of serum S100β before anesthesia and at the end of the surgery | from before anesthesia to after surgery, an anticipated average of 4 hours |