Effect of acupuncture on hormone level in patients with gastrointestinal dysfunction after general anesthesia: A study protocol for a randomized controlled trial

Abstract

Background: Postoperative gastrointestinal dysfunction (PGD) refers to one of the common postoperative complications. Acupuncture can facilitate the recovery of PGD, whereas no therapeutic schedule of acupuncture has been internationally recognized for treating PGD. In the present study, a scientific trial protocol has been proposed to verify the feasibility of acupuncture in treating gastrointestinal dysfunction after laparoscopic cholecystectomy under general anesthesia. We conduct this protocol to investigate whether acupuncture recovery gastrointestinal dysfunction by influencing the expression of gastrointestinal hormone.

Method: The present study refers to a randomized, evaluator blinded, controlled, multi-center clinical trial; it was designed complying with the Consolidated Standards of Reporting Trials (CONSORT 2010) as well as the Standard for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). The subjects will be taken from the inpatients having undergone laparoscopic surgery of Mianyang Affiliated Hospital of Chengdu University of traditional Chinese medicine, Mianyang Third Hospital and Mianyang Anzhou Hospital. Based on the random number yielded using SPSS 25.0 software, the qualified subjects will be randomly classified to the experimental group and the control group. Therapies will be performed 30 min once after operation, the experimental group will be treated with acupuncture, while the control group will receive intravenous injection of granisetron. The major outcome will be the time to first flatus, and the secondary outcomes will include the time to first defecation, abdominal pain, dosage of analgesia pump, abdominal distention, nausea, vomiting, gastrointestinal hormone, as well as mental state. The efficacy and safety of acupuncture will be also assessed following the principle of Good Clinical Practice (GCP).

Discuss: A standardized and scientific clinical trial is conducted to assess the efficacy and safety of acupuncture for gastrointestinal dysfunction after laparoscopic cholecystectomy under general anesthesia. The aim is to objectively evidence and improves the clinical practice of acupoint prescription, as an attempt to promote the clinical application of this technology.

Figure 1

Participant flow diagram.

Figure 2

SPIRIT schedule of schedule of enrollment, interventions, and assessments. t1 is the day before surgery, t0 is the day of the surgery, t1 is 0 to 2 h after surgery, t2 is 2 to 6 h after surgery, t3 is 6 to 12 h after surgery, t4 is 12 to 24 h after surgery, t5 is 24 to 48 h after surgery, t6 is the day of the discharged, t7 is 2 weeks after patients discharged from the hospital.

Figure 3

The acupoints location of the fixed acupuncture prescription.

Figure 4

Visual analog scale.