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

Anesthesia Clinical Trial

— TIGER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323958
• Other study ID #: XJH-A-2014-6-26-01
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: July 25, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• acupoint stimulation
stimulation is given at acupoints
• non-acupoint stimulation
stimulation is given at acupoints
• electrode attached
electrodes are attached to skin

Device:
• electrical stimulation
electrical stimulation is given through electrodes attached to th skin

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View 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.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Richmond Score	status of the patients during emergence	from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
Secondary	Time to extubation		from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
Secondary	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
Secondary	residual sedation		from arriving at PACU to departing from PACU,an anticipated average of 30min
Secondary	PONV	postoperative nausea and vomiting in the PACU	from arriving at PACU to departing from PACU,an anticipated average of 30min
Secondary	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
Secondary	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
Secondary	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
Secondary	serum S100ß	level of serum S100ß before anesthesia and at the end of the surgery	from before anesthesia to after surgery, an anticipated average of 4 hours