Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
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| First Received Date ICMJE | September 3, 2012 | ||||
| Last Updated Date | October 7, 2012 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
the mean infusion rate of intraoperative remifentanil and propofol [ Time Frame: during operation ] [ Designated as safety issue: No ] To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment. |
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| Original Primary Outcome Measures ICMJE |
the mean infusion rate of intraoperative remifentanil and propofol [ Time Frame: from the beginning to the end of infusion ] [ Designated as safety issue: No ] To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment. |
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| Change History | Complete list of historical versions of study NCT01700855 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE |
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| Original Other Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty | ||||
| Official Title ICMJE | Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study | ||||
| Brief Summary | The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty. |
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| Detailed Description | Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | February 2013 | ||||
| Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 29 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01700855 | ||||
| Other Study ID Numbers ICMJE | mazuike-28 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | wangqiang, Xijing Hospital | ||||
| Study Sponsor ICMJE | Xijing Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Xijing Hospital | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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