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Completed

NCT Number: NCT02323958

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupoint stimulation

Other

stimulation is given at acupoints

non-acupoint stimulation

Other

stimulation is given at acupoints

electrode attached

Other

electrodes are attached to skin

Other names: electrode

Electrical Stimulation

Device

electrical stimulation is given through electrodes attached to th skin

Primary outcomes

  1. Time to awake

    Time frame: 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 outcomes

  1. Richmond Score

    Time frame: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour

    status of the patients during emergence

  2. Time to extubation

    Time frame: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour

  3. QoR-15

    Time frame: 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

  4. residual sedation

    Time frame: from arriving at PACU to departing from PACU,an anticipated average of 30min

  5. PONV

    Time frame: from arriving at PACU to departing from PACU,an anticipated average of 30min

    postoperative nausea and vomiting in the PACU

  6. VAS score

    Time frame: from arriving at PACU to departing from PACU,an anticipated average of 30min

    visual analogue score of pain in the PACU, scored 0-10

  7. serum Aquaporin 4

    Time frame: 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

  8. serum MMP9

    Time frame: 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

  9. serum S100β

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: TIGER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2014
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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