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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Other: acupoint stimulation; Other: non-acupoint stimulation; Other: electrode attached; Device: electrical stimulation

• Registration Number: NCT02323958
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupoint stimulation	acupoint stimulation	Electrical stimulation is given through electrodes attached to acupoints
Acupoint stimulation	electrical stimulation	Electrical stimulation is given through electrodes attached to acupoints
Non-acupoint stimulation	electrical stimulation	Electrical stimulation is given through electrodes attached to non-acupoints
Non-acupoint stimulation	electrode attached	Electrical stimulation is given through electrodes attached to non-acupoints
Control stimulation	electrode attached	Electrode attached but no stimulation is given
Acupoint stimulation	electrode attached	Electrical stimulation is given through electrodes attached to acupoints
Non-acupoint stimulation	non-acupoint stimulation	Electrical stimulation is given through electrodes attached to non-acupoints

Primary Outcome Measures

Name	Time	Method
Time to awake	from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour	time to open eyes to verbal command

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China