C.Delivery; Surgery (Previous), GynecologicalNCT02619578
The Effect of TEAS on the Quality of Early Recovery
A study testing TEAS, Con and propofol, remifentanil, vecuronium in people with C.Delivery; Surgery (Previous), Gynecological and Inappropriate Device Stimulation of Tissue, run by Guizhou Provincial People's Hospital.
Trial summary
During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. Read more about this study
- Who is it for?
- Ages 29 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- C.Delivery; Surgery (Previous), Gynecological, Inappropriate Device Stimulation of Tissue, Delayed Emergence From Anesthesia
- What is being tested?
- TEAS, Con and propofol, remifentanil, vecuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2014
- 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 29 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing elective gynecological laparoscopic surgery.
- ASA physical status of I-II.
- Ages ranged from 29-60 yr.
Who cannot join
- Recent use of TEAS or acupuncture.
- Neural damage or infection along the meridian at which the acupoints lay.
- Use of antiemetic in the previous week.
- Regular use of opioids.
- Hepatic dysfunction.
- Confirmed renal impairment. Diabetes mellitus Cognitive dysfunction Conversion to laparotomy during gynecologic laparoscopy.
About this study
Official title: The Effect of Transcutaneous Electric Acupoint Stimulation on the Quality of Early Recovery in Patients Undergoing Gynecological Laparoscopic Surgery: a Prospective, Randomized, Placebo-controlled Trial
During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia, which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the concentration of plasma catecholamines, cortisol and vasopressin , these responses have an important impact on patient recovery after surgery.
Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on acupuncture, has been widely accepted and used worldwide. To date, multiple studies have demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function. However, whether TEAS could improve the quality of early recovery after gynecologic laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the quality of early recovery in the patients undergoing gynecological laparoscopic surgery.
Read the detailed description
Patient population Sixty patients undergoing elective gynecological laparoscopic surgery at Guizhou province people's hospital with an ASA physical status of I-II were recruited between November 2013 and November 2014. Their ages ranged from 29-60 yr. Exclusion criteria were recent use of TEAS or acupuncture, neural damage or infection along the meridian at which the acupoints lay, use of antiemetic in the previous week, regular use of opioids, hepatic dysfunction, confirmed renal impairment, diabetes mellitus, cognitive dysfunction and conversion to laparotomy during gynecologic laparoscopy.
Randomization and blinding Patients were assigned to either TEAS stimulus (TEAS group) or control group (Con group) on the basis of random numbers generated by a computer. Only the acupuncturist was informed the randomization allocation, just before the onset of TEAS. None of the anesthesiologists, surgeons, physicians in the post-anesthesia care unit (PACU), or participants were aware of the allocation. Blinding of the patients was ensured by using gel electrodes in the same therapeutic setting, which has previously been proved to be a successful strategy.
TEAS protocol An experienced acupuncturist performed TEAS for 30 min before anesthesia. According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization. Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation. The patients in the control group had the electrodes applied but received no stimulation.
Anesthesia and perioperative management One surgeon conducted all surgeries according to a standard protocol; surgery commenced between 8:30 and 1:00 p.m. Anesthesia was induced i.v. with propofol and remifentanil using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v., and patients were orotracheally intubed 5 min later. Anesthesia was maintained with TCI of propofol and remifentanil. The depth of anesthesia was monitored using index (BIS). Effect site concentrations of propofol and remifentanil were adjusted to the hemodynamic and BIS. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. In both groups, remifentanil and propofol infusions were stopped 5 min before the end of surgery. Patients were extubated and transferred to the PACU after surgery.
Data collection Baseline data included demographics, body mass index (BMI), and ASA physical status. Surgical information recorded included anesthesia duration, surgery duration, estimated blood loss, and all other intraoperative medications. Postoperative data were collected regarding the incidence of nausea and vomiting, postoperative pain medications and antiemetics.
The Quality of Recovery-40 (QoR-40) is a validated scale with 5 domains 10-12. These measure physical comfort, emotional state, physical independence, psychological support, and pain. Each domain is scored to a maximum global score of 200. QoR-40 scores have been found to be associated with both quality-of-life scales and patient satisfaction indices 13 as well as postoperative pain 14. In the present study, QoR-40 evaluation was performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Visual analog scales (VAS) are widely used in behavioral science and previous studies reported their usefulness and validity 15, 16. VAS scores at rest queried about their level of pain on postoperative day 1 (T1) and postoperative day 2 (T2).
The Mini-Mental State Examination (MMSE) is one of the most widely used assessment instruments of cognitive functioning postoperatively, which screens domains of orientation to time and place, attention and memory, concentration, language and praxis 17. Patient cognitive function was assessed using the MMSE on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Statistical analysis All statistical analyses were performed using SPSS 13.0 (SPSS, Inc., Chicago, IL, USA). Continuous variables are presented as mean (SD) and compared using the unpaired Student's-test. Dichotomus variables were presented as the number of patients (percent) and analyzed using the X2 test. The level of significance for all statistical tests was set at 0.05.
- Conditions
- C.Delivery; Surgery (Previous), Gynecological, Inappropriate Device Stimulation of Tissue, Delayed Emergence From Anesthesia
- Being tested
- TEAS, Con, propofol, remifentanil, vecuronium, mechanical ventilation
- Keywords
- Transcutaneous electric acupoint stimulation (TEAS), gynecological laparoscopic surgery, QoQ-40, MMSE, VAS
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASOther
According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization . Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation.
ConOther
The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation.
propofol, remifentanil, vecuroniumDrug
Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v.
mechanical ventilationOther
Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.
| Study group | Role | What they receive |
|---|---|---|
| TEAS Group | Other | TEAS consisted of 30 min of stimulation (12-15 mA, 2/100 Hz) at the Hegu (L14) and Neiguan (PC6) before anesthesia. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. Receives: Other: TEAS; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation |
| Con Group | Other | The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. Receives: Other: Con; Drug: propofol, remifentanil, vecuronium; Other: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on QoR-40
Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Measured: 1 year
Secondary outcomes (2)
Scores on MMSE
mini-mental state examination (MMSE) scores performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Measured: 1 year
Scores on VAS
A 100-mm visual analogue scale (VAS) scores at rest performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for C.Delivery; Surgery (Previous), GynecologicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guizhou Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619578
- Sponsor's protocol ID
- A14-30323
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu X, Zhang F, Chen B. The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial. Trials. 2020 Jan 8;21(1):43. doi: 10.1186/s13063-019-3892-4.
PubMed 31915045
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electric Acupoint Stimulation on the Quality of Early Recovery in Patients Undergoing Gynecological Laparoscopic Surgery: a Prospective, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02619578
- Acronym / sponsor ID
- A14-30323
- Conditions
- C.Delivery; Surgery (Previous), Gynecological, Inappropriate Device Stimulation of Tissue, Delayed Emergence From Anesthesia
- Keywords
- Transcutaneous electric acupoint stimulation (TEAS), gynecological laparoscopic surgery, QoQ-40, MMSE, VAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guizhou Provincial People's HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Dec 2015 (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.
During the past four decades, gynecologic laparoscopy has evolved from a limited method to an advanced operative approach that frequently serves as a substitute for laparotomy. The advantages of laparoscopy over laparotomy include less postoperative pain, shorter hospital stays, and reduced blood loss. However, in the surgery CO2 increases the intra-abdominal and intrathoracic pressure, which leads to cardiac output decrease and increases sympathetic activity in a reflex. On the other hand, CO2 accumulation in the body leads to hypercapnia, which indirectly stimulates aortic body chemosensory organs and carotid sinus, increasing the concentration of plasma catecholamines, cortisol and vasopressin , these responses have an important impact on patient recovery after surgery.
Acupuncture is an ancient Chinese method to treat diseases and relieve pain. Transcutaneous electrical acupoint stimulation (TEAS), a noninvasive adjunctive intervention based on acupuncture, has been widely accepted and used worldwide. To date, multiple studies have demonstrated TEAS could reduce intra-operative opioid drugs consumption, reduce the incidence of postoperative nausea and vomiting (PONV) and improve postoperative cognitive function. However, whether TEAS could improve the quality of early recovery after gynecologic laparoscopy is unknown. In this study we therefore investigated the effects of TEAS at the acupoints of Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) on the quality of early recovery in the patients undergoing gynecological laparoscopic surgery.
Detailed description
Patient population Sixty patients undergoing elective gynecological laparoscopic surgery at Guizhou province people's hospital with an ASA physical status of I-II were recruited between November 2013 and November 2014. Their ages ranged from 29-60 yr. Exclusion criteria were recent use of TEAS or acupuncture, neural damage or infection along the meridian at which the acupoints lay, use of antiemetic in the previous week, regular use of opioids, hepatic dysfunction, confirmed renal impairment, diabetes mellitus, cognitive dysfunction and conversion to laparotomy during gynecologic laparoscopy.
Randomization and blinding Patients were assigned to either TEAS stimulus (TEAS group) or control group (Con group) on the basis of random numbers generated by a computer. Only the acupuncturist was informed the randomization allocation, just before the onset of TEAS. None of the anesthesiologists, surgeons, physicians in the post-anesthesia care unit (PACU), or participants were aware of the allocation. Blinding of the patients was ensured by using gel electrodes in the same therapeutic setting, which has previously been proved to be a successful strategy.
TEAS protocol An experienced acupuncturist performed TEAS for 30 min before anesthesia. According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization. Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation. The patients in the control group had the electrodes applied but received no stimulation.
Anesthesia and perioperative management One surgeon conducted all surgeries according to a standard protocol; surgery commenced between 8:30 and 1:00 p.m. Anesthesia was induced i.v. with propofol and remifentanil using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v., and patients were orotracheally intubed 5 min later. Anesthesia was maintained with TCI of propofol and remifentanil. The depth of anesthesia was monitored using index (BIS). Effect site concentrations of propofol and remifentanil were adjusted to the hemodynamic and BIS. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. In both groups, remifentanil and propofol infusions were stopped 5 min before the end of surgery. Patients were extubated and transferred to the PACU after surgery.
Data collection Baseline data included demographics, body mass index (BMI), and ASA physical status. Surgical information recorded included anesthesia duration, surgery duration, estimated blood loss, and all other intraoperative medications. Postoperative data were collected regarding the incidence of nausea and vomiting, postoperative pain medications and antiemetics.
The Quality of Recovery-40 (QoR-40) is a validated scale with 5 domains 10-12. These measure physical comfort, emotional state, physical independence, psychological support, and pain. Each domain is scored to a maximum global score of 200. QoR-40 scores have been found to be associated with both quality-of-life scales and patient satisfaction indices 13 as well as postoperative pain 14. In the present study, QoR-40 evaluation was performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Visual analog scales (VAS) are widely used in behavioral science and previous studies reported their usefulness and validity 15, 16. VAS scores at rest queried about their level of pain on postoperative day 1 (T1) and postoperative day 2 (T2).
The Mini-Mental State Examination (MMSE) is one of the most widely used assessment instruments of cognitive functioning postoperatively, which screens domains of orientation to time and place, attention and memory, concentration, language and praxis 17. Patient cognitive function was assessed using the MMSE on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
Statistical analysis All statistical analyses were performed using SPSS 13.0 (SPSS, Inc., Chicago, IL, USA). Continuous variables are presented as mean (SD) and compared using the unpaired Student's-test. Dichotomus variables were presented as the number of patients (percent) and analyzed using the X2 test. The level of significance for all statistical tests was set at 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS Group | Other | Other: TEAS, Drug: propofol, remifentanil, vecuronium, Other: mechanical ventilationTEAS consisted of 30 min of stimulation (12-15 mA, 2/100 Hz) at the Hegu (L14) and Neiguan (PC6) before anesthesia. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. |
| Con Group | Other | Other: Con, Drug: propofol, remifentanil, vecuronium, Other: mechanical ventilationThe patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation. Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. |
Who may qualify
- Ages
- 29 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing elective gynecological laparoscopic surgery.
- ASA physical status of I-II.
- Ages ranged from 29-60 yr.
Key exclusion criteria (6 listed)
- Recent use of TEAS or acupuncture.
- Neural damage or infection along the meridian at which the acupoints lay.
- Use of antiemetic in the previous week.
- Regular use of opioids.
- Hepatic dysfunction.
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 |
|---|---|---|
| TEASAccording to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization . Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation. | Other | TEAS Group |
| ConThe patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation. | Other | Con Group |
| propofol, remifentanil, vecuroniumAnesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v. | Drug | Con Group, TEAS Group |
| mechanical ventilationPatients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation. | Other | Con Group, TEAS Group |
Primary outcome
Scores on QoR-40
Time frame: 1 year
Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1(T0), postoperative day 1 (T1) and postoperative day 2 (T2).
2 secondary outcomes
Scores on MMSE
Time frame: 1 year
Scores on VAS
Time frame: 1 year
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 2 Dec 2015.
- Derived from this study: PubMed 31915045Yu X, Zhang F, Chen B. The effect of TEAS on the quality of early recovery in patients undergoing gynecological laparoscopic surgery: a prospective, randomized, placebo-controlled trial. Trials. 2020 Jan 8;21(1):43. doi: 10.1186/s13063-019-3892-4.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS, Con and propofol, remifentanil, vecuronium in people with C.Delivery; Surgery (Previous), Gynecological and Inappropriate Device Stimulation of Tissue, run by Guizhou Provincial People's Hospital.
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 3 inclusion and 6 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Scores on QoR-40 (time frame: 1 year). 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 NCT02619578, which also lists 1 linked publication.
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 2 Dec 2015.