Perioperative Transcutaneous Electrical Acupoint Stimulation for Enhanced Recovery After Laparoscopic Colon Surgery:a Multi-center Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Recovery
- Sponsor
- Zhihong LU
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Time to meeting discharge criteria
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to observe the effects of transcutaneous electrical acupoint stimulation(TEAS) on postoperative recovery after laparoscopic colon surgery.
Detailed Description
Patients were randomly assigned to two groups, receiving TEAS andno stimulation respectively. Interventions were given 30min before anesthesia and 1, 2 , 3 day after surgery, lasted 30min each time . The acupoints of TEAS group are bilateral ST36/SP6 combined with PC6/LI4, and the control group only attach electrodes without electric current. The frequency of TEAS is set to 2/10 Hz. After surgery, the time of meeting discharge criteria, first flatus and defecation were recorded. Score of PONV, life quality, sleep quality and VAS of pain were evaluated 24, 48 and 72h after surgery. The postoperative complications, re-exploration, cost of hospitalization and adverse events were also recorded.
Investigators
Zhihong LU
Doctor
Air Force Military Medical University, China
Eligibility Criteria
Inclusion Criteria
- •Age between 18 to 75 years old；
- •ASA I-III；
- •Scheduled for elective laparoscopic colon surgery under general anesthesia；
- •BMI between 18 and 30；
- •Informed consented.
Exclusion Criteria
- •Patients with contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints；
- •Patients with difficulty in communication；
- •Emergency surgery；
- •Patients who are with distant metastasis;
- •Patients who are with history of myocardial infarction or cerebral infarction in the past six months；
- •Patients who are with long history of taking NSAIDS，hormone or immunosuppressive agents；
- •Patients who are recruited in other clinical trials in the last 3 months；
- •Other situations researcher think shouldn't be included.
Outcomes
Primary Outcomes
Time to meeting discharge criteria
Time Frame: end of the surgery to discharge,with an average of 7 days
Secondary Outcomes
- Time to first flatus(end of the surgery to discharge,with an average of 7 days)
- Time to first defecation(end of the surgery to discharge,with an average of 7 days)
- Incidence of postoperative complications(end of the surgery to discharge,with an average of 7 days)
- Time to first oral intake of water(end of the surgery to discharge,with an average of 7 days)
- quality of sleeping score(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- quality of recovery(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- visual analogue scale(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- incidence of nausea and vomiting(end of surgery to 24 hours, 48 hours, and 72 hours after surgery)
- expense(end of the surgery to discharge,with an average of 7 days)