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

A

Air Force Military Medical University of People's Liberation Army

Status

Completed

Conditions

Anesthesia

Treatments

Other: non-acupoint stimulation
Other: acupoint stimulation
Other: electrode attached
Device: electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02323958
XJH-A-2014-6-26-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 3 patient groups, including a placebo group

Acupoint stimulation
Experimental group
Description:
Electrical stimulation is given through electrodes attached to acupoints
Treatment:
Device: electrical stimulation
Other: electrode attached
Other: acupoint stimulation
Non-acupoint stimulation
Placebo Comparator group
Description:
Electrical stimulation is given through electrodes attached to non-acupoints
Treatment:
Device: electrical stimulation
Other: electrode attached
Other: non-acupoint stimulation
Control stimulation
Sham Comparator group
Description:
Electrode attached but no stimulation is given
Treatment:
Other: electrode attached

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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