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

July 25, 2017 updated by: Zhihong LU, Air Force Military Medical University, China

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupoint stimulation
Electrical stimulation is given through electrodes attached to acupoints
Other: acupoint stimulation
stimulation is given at acupoints
Other: electrode attached
electrodes are attached to skin
Other Names:
  • electrode
Device: electrical stimulation
electrical stimulation is given through electrodes attached to th skin
Placebo Comparator: Non-acupoint stimulation
Electrical stimulation is given through electrodes attached to non-acupoints
Other: electrode attached
electrodes are attached to skin
Other Names:
  • electrode
Device: electrical stimulation
electrical stimulation is given through electrodes attached to th skin
Other: non-acupoint stimulation
stimulation is given at acupoints
Sham Comparator: Control stimulation
Electrode attached but no stimulation is given
Other: electrode attached
electrodes are attached to skin
Other Names:
  • electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
Time to extubation
Time Frame: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
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
from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour
residual sedation
Time Frame: from arriving at PACU to departing from PACU,an anticipated average of 30min
from arriving at PACU to departing from PACU,an anticipated average of 30min
PONV
Time Frame: from arriving at PACU to departing from PACU,an anticipated average of 30min
postoperative nausea and vomiting in the PACU
from arriving at PACU to departing from PACU,an anticipated average of 30min
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
from arriving at PACU to departing from PACU,an anticipated average of 30min
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
from before anesthesia to after surgery, an anticipated average of 4 hours
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
from before anesthesia to after surgery, an anticipated average of 4 hours
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
from before anesthesia to after surgery, an anticipated average of 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Study Chair: Hailong Dong, PhD, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • XJH-A-2014-6-26-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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