AnesthesiaTIGERNCT02323958
TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery
A study testing acupoint stimulation, non-acupoint stimulation and electrode attached in people with Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- acupoint stimulation, non-acupoint stimulation and electrode attached
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia
- Patients with written informed consent
Who cannot join
- Patients with difficulty in communication
- Patients with disease of central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- acupoint stimulation, non-acupoint stimulation, electrode attached, electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint stimulationOther
stimulation is given at acupoints
non-acupoint stimulationOther
stimulation is given at acupoints
electrode attachedOther
Also called electrode
electrodes are attached to skin
electrical stimulationDevice
electrical stimulation is given through electrodes attached to th skin
| Study group | Role | What they receive |
|---|---|---|
| Acupoint stimulation | Experimental | Electrical stimulation is given through electrodes attached to acupoints Receives: Other: acupoint stimulation; Other: electrode attached; Device: electrical stimulation |
| Non-acupoint stimulation | Placebo comparator | Electrical stimulation is given through electrodes attached to non-acupoints Receives: Other: non-acupoint stimulation; Other: electrode attached; Device: electrical stimulation |
| Control stimulation | Sham comparator | Electrode attached but no stimulation is given Receives: Other: electrode attached |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to awake
time to open eyes to verbal command
Measured: from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour
Secondary outcomes (9)
Richmond Score
status of the patients during emergence
Measured: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
Time to extubation
Measured: from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour
QoR-15
Score of quality of recovery using a 15 items questionaire
Measured: from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour
residual sedation
Measured: from arriving at PACU to departing from PACU,an anticipated average of 30min
PONV
postoperative nausea and vomiting in the PACU
Measured: from arriving at PACU to departing from PACU,an anticipated average of 30min
VAS score
visual analogue score of pain in the PACU, scored 0-10
Measured: from arriving at PACU to departing from PACU,an anticipated average of 30min
serum Aquaporin 4
level of serum Aquaporin 4 before anesthesia and at the end of the surgery
Measured: from before anesthesia to after surgery, an anticipated average of 4 hours
serum MMP9
level of serum Matrix metallop roteinase before anesthesia and at the end of the surgery
Measured: from before anesthesia to after surgery, an anticipated average of 4 hours
serum S100β
level of serum S100β before anesthesia and at the end of the surgery
Measured: from before anesthesia to after surgery, an anticipated average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Hailong Dong, PhD, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323958
- Sponsor's protocol ID
- XJH-A-2014-6-26-01
- Acronym
- TIGER
- Status last verified
- Jul 2017
- First submitted
- 8 Dec 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24256501Pandey 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.
PubMed 21268573
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Outcome During Emergence From Anesthesia in Patients Undergoing Robotic Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT02323958
- Acronym / sponsor ID
- TIGER / XJH-A-2014-6-26-01
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupoint stimulation | Experimental | Other: acupoint stimulation, Other: electrode attached, Device: electrical stimulationElectrical stimulation is given through electrodes attached to acupoints |
| Non-acupoint stimulation | Placebo comparator | Other: non-acupoint stimulation, Other: electrode attached, Device: electrical stimulationElectrical stimulation is given through electrodes attached to non-acupoints |
| Control stimulation | Sham comparator | Other: electrode attachedElectrode attached but no stimulation is given |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia
- Patients with written informed consent
Key exclusion criteria (2 listed)
- Patients with difficulty in communication
- Patients with disease of central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupoint stimulationstimulation is given at acupoints | Other | Acupoint stimulation |
| non-acupoint stimulationstimulation is given at acupoints | Other | Non-acupoint stimulation |
| electrode attachedAlso: electrodeelectrodes are attached to skin | Other | Acupoint stimulation, Control stimulation, Non-acupoint stimulation |
| electrical stimulationelectrical stimulation is given through electrodes attached to th skin | Device | Acupoint stimulation, Non-acupoint stimulation |
Primary outcome
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
9 secondary outcomes
Richmond Score
Time frame: 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
QoR-15
Time frame: 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
PONV
Time frame: 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
serum Aquaporin 4
Time frame: 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
serum S100β
Time frame: from before anesthesia to after surgery, an anticipated average of 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Results publication: PubMed 24256501Schramm 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.
- Results publication: PubMed 21268573Pandey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailong Dong, PhD study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint stimulation, non-acupoint stimulation and electrode attached in people with Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to awake (time frame: from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.