Clinical trial NCT02323958: TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Outcome During Emergence From Anesthesia in Patients Undergoing Robotic Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to awake
timeFrame: from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour
Secondary outcomes:
measure: Richmond Score
timeFrame: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
measure: Time to extubation
timeFrame: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
measure: QoR-15
timeFrame: from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour
measure: residual sedation
timeFrame: from arriving at PACU to departing from PACU,an anticipated average of 30min
measure: PONV
timeFrame: from arriving at PACU to departing from PACU,an anticipated average of 30min
measure: VAS score
timeFrame: from arriving at PACU to departing from PACU,an anticipated average of 30min
measure: serum Aquaporin 4
timeFrame: from before anesthesia to after surgery, an anticipated average of 4 hours
measure: serum MMP9
timeFrame: from before anesthesia to after surgery, an anticipated average of 4 hours
measure: serum S100β
timeFrame: from before anesthesia to after surgery, an anticipated average of 4 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Hailong Dong, PhD
role: STUDY_CHAIR
References:
citation: Schramm P, Treiber AH, Berres M, Pestel G, Engelhard K, Werner C, Closhen D. Time course of cerebrovascular autoregulation during extreme Trendelenburg position for robotic-assisted prostatic surgery. Anaesthesia. 2014 Jan;69(1):58-63. doi: 10.1111/anae.12477. Epub 2013 Nov 20.
citation: Pandey R, Garg R, Darlong V, Punj J, Chandralekha, Kumar A. Unpredicted neurological complications after robotic laparoscopic radical cystectomy and ileal conduit formation in steep trendelenburg position: two case reports. Acta Anaesthesiol Belg. 2010;61(3):163-6.