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IRCT20240123060780N4 IRCT 2026-03-16 Kermanshah University of Medical Sciences Effects of skin electrical stimulation at acupuncture points on hemodynamics, pain, nausea and vomiting during anesthesia Effects of skin electrical stimulation at acupuncture points PC6, ST36 and LI4 on hemodynamics, pain, nausea and vomiting during anesthesia in patients requiring elective laparoscopic cholecystectomy 2026-03-21 anticipated 70 Complete https://irct.ir/trial/89227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of samples in this study is done by the Randomization Main computer software. Given the presence of two groups, a random sequence of the letters I and C is created in blocks with a random number of 2 letters. Each letter symbolizes one of the study groups. Then these blocks are placed in sealed envelopes. One of the blinded researchers opens one of the envelopes before the start of the study and finally the patient is placed in one of the groups, Blinding description: In the control group (C); the electrodes of the electrical stimulation device are placed at the acupuncture points, but the stimulation device is inactive. In the intervention group (I); the stimulation electrodes are placed at the acupuncture points and connected to the electrical stimulation device with active function. Due to the identical apparent interventions and the patient's lack of knowledge of the stimulation group and intervention, the patients were blinded to the intervention. In the control group, the stimulation device is turned off and no real stimulation is applied. Given that the patients in the intervention group may feel the stimulation, the current threshold level is considered minimal. In addition, most of the stimulation period occurs during the patient's anesthesia and the patient is not conscious and alert. Electrical stimulation is performed by one study colleague and the recording of study variables is performed by another study colleague who was blinded to the grouping. Therefore, two study assistants are observed. 3 Pain. Intervention 1: Intervention group: Stimulation electrodes are placed bilaterally at the Hugo (LI4), Niguan (PC6), and Zusanli (ST36) acupuncture points and connected to an active electrical stimulation device. The current is set to 5 mA for the upper limb and 10 mA for the lower limb with a frequency of 100 Hz. Intervention 2: Control group: Stimulation electrodes are placed bilaterally at the Hugo (LI4), Niguan (PC6), and Zusanli (ST36) acupuncture points and connected to an electrical stimulation device with passive function. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Javad Aminisaman
School of Medicine, Daneshgah Street, Shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 aminisamanj99@gmail.com Kermanshah University of Medical Sciences scientific Javad Aminisaman
School of Medicine, Daneshgah Street, Shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 aminisamanj99@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Female patients requiring elective laparoscopic cholecystectomy who have anesthesia risk levels 1 and 2 according to the American Society of Anesthesiologists (ASA) classification Reading literacy Healthy speech and vision abilities The skin in the area of ​​electrical stimulation be healthy 25 years 60 years Female Peripheral edema in the area of ​​stimulation History of smoking or drug use Use of analgesic or anti-nausea and vomiting medications in the past 24 hours The patient's previous complicated surgical and anesthetic history at the time of the history taking. Pregnancy Breastfeeding Taking sedatives History of diabetes History of vascular disease Having pacemakers and implantable cardiac defibrillators G89.1 Acute pain, not elsewhere classified Treatment - Devices Placebo Intervention group: Stimulation electrodes are placed bilaterally at the Hugo (LI4), Niguan (PC6), and Zusanli (ST36) acupuncture points and connected to an active electrical stimulation device. The current is set to 5 mA for the upper limb and 10 mA for the lower limb with a frequency of 100 Hz. Control group: Stimulation electrodes are placed bilaterally at the Hugo (LI4), Niguan (PC6), and Zusanli (ST36) acupuncture points and connected to an electrical stimulation device with passive function. Heart rate. Timepoint: Heart rate is measured before and after laryngoscopy (insertion of the endotracheal tube), before and after removal of the endotracheal tube, and every 15 minutes during anesthesia. Method of measurement: Using patient-attached monitoring. Systolic and diastolic blood pressure. Timepoint: Blood pressure is measured before and after laryngoscopy (insertion of the endotracheal tube), before and after removal of the endotracheal tube, and every 15 minutes during anesthesia. Method of measurement: Using patient-attached monitoring. Pain. Timepoint: Postoperative pain levels are measured in the recovery area and at 6, 12, and 24 hours after the operation. Method of measurement: Based on the Visual Analog Scale (VAS). Severity of postoperative nausea and vomiting. Timepoint: Within 24 hours after surgery. Method of measurement: Using the Simplified PONV Impact Scale. Opioid analgesic dosage. Timepoint: Within 24 hours after surgery. Method of measurement: Dosage in milligrams based on the patient's record. Bispectral Index (BIS). Timepoint: Before induction of anesthesia, before and after laryngoscopy, every 15 minutes during anesthesia, and before and after tracheal extubation. Method of measurement: Measured using a patient-attached bispectral index (BIS) monitor. Kermanshah University of Medical Sciences Approved 2026-02-22 Ethics committee of Kermanshah University of Medical Sciences No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)