Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631160
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2018-07-02
Brief Title:
Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients
Sponsor:
Tianjin Nankai Hospital
Organization:
Tianjin Nankai Hospital
Study Overview
Official Title:
Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy PatientsA Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Title Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patientsA Randomized Clinical Trial
2 Research center Multicenter
3 Design of the research A randomized double-blind and parallel controlled study
4 Object of the research Patients 40age75 yearsplaning to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter
5 Sample size of the research A total of 1200 patients600 cases in each group
6 Interventions The acupuncture points for Transcutaneous Acupoint Electrical StimulationTAES are Zhongji CV3Guanyuan CV4Sanyinjiao SP6 and Ciliao BL32 points In treatment group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus HANS G6805-2 Huayi Co Shanghai China at bilateral of SP6 and BL 32 points during the operationand treated with a similar method at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit Each devic is connected and maintained after Deqi Participants in the control group received nonacupoints located 1 inch beside acupoints and avoided manual stimulation and no Deqi without actual current output
7 Aim of the research Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy LC
8 OutcomePrimary outcomes The time of the first spontaneous voiding after surgery
Secondary outcomes symptoms of postoperative voiding the incidence of Postoperative dysuriapostoperative catheterization rate catheterization time incidence of related complicationsas well as the effects on postoperative NRS pain and sleep quality scores etc
9 The estimated duration of the study2 years
2 Research center Multicenter
3 Design of the research A randomized double-blind and parallel controlled study
4 Object of the research Patients 40age75 yearsplaning to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter
5 Sample size of the research A total of 1200 patients600 cases in each group
6 Interventions The acupuncture points for Transcutaneous Acupoint Electrical StimulationTAES are Zhongji CV3Guanyuan CV4Sanyinjiao SP6 and Ciliao BL32 points In treatment group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus HANS G6805-2 Huayi Co Shanghai China at bilateral of SP6 and BL 32 points during the operationand treated with a similar method at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit Each devic is connected and maintained after Deqi Participants in the control group received nonacupoints located 1 inch beside acupoints and avoided manual stimulation and no Deqi without actual current output
7 Aim of the research Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy LC
8 OutcomePrimary outcomes The time of the first spontaneous voiding after surgery
Secondary outcomes symptoms of postoperative voiding the incidence of Postoperative dysuriapostoperative catheterization rate catheterization time incidence of related complicationsas well as the effects on postoperative NRS pain and sleep quality scores etc
9 The estimated duration of the study2 years
Detailed Description:
This study is a large sample randomized double-blinded placebo-controlled and long-term follow-up design In this study bilateralZhongji CV3Guanyuan CV4Sanyinjiao SP6 and Ciliao BL32 points were selected for perioperative TAES treatment accompanied with evaluating the postoperative spontaneous voiding the incidence of Postoperative dysuriapostoperative catheterization rate as well as the effects on postoperative NRS pain and sleep quality scores To clarify the effect of TAES on the postoperative spontaneous voiding in patients for laparoscopic surgery is of great significance to the clinical applications and popularization of traditional acupuncture treatment perioperatively across the world
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None