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
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General information
35
70
3570
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70
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2026-04-02, 1405/01/13
2026-03-21, 1405/01/01
2026-0403-0221 00:00:00
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2026-03-22, 1405/01/02
2026-03-22 00:00:00
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2026-06-22, 1405/04/01
2026-06-22 00:00:00
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2026-06-23, 1405/04/02
2026-06-23 00:00:00
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Updating study start and end dates
Updating study start and end dates
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بروز رسانی تاریخ های شروع و خاتمه مطالعه
بروز رسانی تاریخ های شروع و خاتمه مطالعه
Primary outcomes
#1
Pain
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Pain
درد
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درد
Postoperative pain is measured during recovery and at 6, 12, and 24 hours after surgery.
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Postoperative pain is measured during recovery and at 6, 12, and 24 hours after surgery.
میزان درد بعد از عمل در ریکاوری و در ساعات 6، 12 و 24 بعد از عمل اندازه گیری می شود.
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میزان درد بعد از عمل در ریکاوری و در ساعات 6، 12 و 24 بعد از عمل اندازه گیری می شود.
Based on visual analogue scale (VAS)
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Based on visual analogue scale (VAS)
براساس معیار اندازه گیری بصری (VAS)
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براساس معیار اندازه گیری بصری (VAS)
#2
Severity of postoperative nausea and vomiting
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Severity of postoperative nausea and vomiting
شدت تهوع و استفراغ بعد از عمل
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شدت تهوع و استفراغ بعد از عمل
Within 24 hours after surgery
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Within 24 hours after surgery
در طول 24 ساعت بعد از عمل
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در طول 24 ساعت بعد از عمل
It is performed using the Simplified PONV Impact Scale tool.
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It is performed using the Simplified PONV Impact Scale tool.
با استفاده از ابزار Simplified PONV Impact Scale انجام می شود.
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با استفاده از ابزار Simplified PONV Impact Scale انجام می شود.
#3
Amount of analgesia taken
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Amount of analgesia taken
میزان مصرف ضد درد
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میزان مصرف ضد درد
Within 24 hours after surgery
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Within 24 hours after surgery
در طول 24 ساعت بعد از عمل
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در طول 24 ساعت بعد از عمل
Dosage in milligrams according recording in patient file
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Dosage in milligrams according recording in patient file
میزان مصرف بر حسب میلی گرم براساس پرونده بیمار
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میزان مصرف بر حسب میلی گرم براساس پرونده بیمار
Secondary outcomes
#1
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Pain
Pain
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درد
درد
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Postoperative pain levels are measured in the recovery area and at 6, 12, and 24 hours after the operation.
Postoperative pain levels are measured in the recovery area and at 6, 12, and 24 hours after the operation.
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میزان درد بعد از عمل در ریکاوری و در ساعات 6، 12 و 24 بعد از عمل اندازه گیری می شود.
میزان درد بعد از عمل در ریکاوری و در ساعات 6، 12 و 24 بعد از عمل اندازه گیری می شود.
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Based on the Visual Analog Scale (VAS)
Based on the Visual Analog Scale (VAS)
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بر اساس معیار اندازه گیری بصری (VAS)
بر اساس معیار اندازه گیری بصری (VAS)
#2
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Severity of postoperative nausea and vomiting
Severity of postoperative nausea and vomiting
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شدت تهوع و استفراغ بعد از عمل
شدت تهوع و استفراغ بعد از عمل
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Within 24 hours after surgery
Within 24 hours after surgery
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در طول 24 ساعت بعد از عمل
در طول 24 ساعت بعد از عمل
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Using the Simplified PONV Impact Scale
Using the Simplified PONV Impact Scale
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با استفاده ار ابزار Simplified PONV impact scale
با استفاده ار ابزار Simplified PONV impact scale
#3
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Opioid analgesic dosage
Opioid analgesic dosage
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میزان مصرف ضد درد مخدری
میزان مصرف ضد درد مخدری
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Within 24 hours after surgery
Within 24 hours after surgery
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در طول 24 ساعت بعد از عمل
در طول 24 ساعت بعد از عمل
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Dosage in milligrams based on the patient's record
Dosage in milligrams based on the patient's record
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میزان مصرف بر حسب میلیگرم بر اساس پرونده بیمار
میزان مصرف بر حسب میلیگرم بر اساس پرونده بیمار
#4
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Bispectral Index (BIS)
Bispectral Index (BIS)
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شاخص دوطیفی (Bispectral Index; BIS)
شاخص دوطیفی (Bispectral Index; BIS)
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Before induction of anesthesia, before and after laryngoscopy, every 15 minutes during anesthesia, and before and after tracheal extubation.
Before induction of anesthesia, before and after laryngoscopy, every 15 minutes during anesthesia, and before and after tracheal extubation.
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قبل از القای بیهوشی، قبل و بعد از لارنگوسکوپی، هر ۱۵ دقیقه در طول بیهوشی و قبل و بعد از خارج کردن لوله تراشه.
قبل از القای بیهوشی، قبل و بعد از لارنگوسکوپی، هر ۱۵ دقیقه در طول بیهوشی و قبل و بعد از خارج کردن لوله تراشه.
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Measured using a patient-attached bispectral index (BIS) monitor.
Measured using a patient-attached bispectral index (BIS) monitor.
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با استفاده از مانیتور BIS متصل به بیمار.
با استفاده از مانیتور BIS متصل به بیمار.
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Javad Aminisaman
Full name of responsible person - Persian: جواد امینی سامان
Street address - English: Imam Khomeini hospital ,Naghlye street, Kermanshah
Street address - Persian: کرمانشاه، خیابان نقلیه، بیمارستان امام خمینی
City - English: Kermanshah
City - Persian: Kermanshah
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6718743161
Phone: +98 83 3728 3602
Fax:
Email: aminisamanj99@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Javad Aminisaman
Full name of responsible person - Persian: جواد امینی سامان
Street address - English: Imam Khomeini hospital ,Naghlye street, Kermanshah
Street address - Persian: کرمانشاه، خیابان نقلیه، بیمارستان امام خمینی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6718743161
Phone: +98 83 3728 3602
Fax:
Email: aminisamanj99@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Javad Aminisaman Full name of responsible person - Persian: جواد امینی سامان Street address - English: Imam Khomeini hospital ,Naghlye street, Kermanshah Street address - Persian: کرمانشاه، خیابان نقلیه، بیمارستان امام خمینی City - English: Kermanshah City - Persian: Kermanshahکرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6718743161 Phone: +98 83 3728 3602 Fax: Email: aminisamanj99@gmail.com Web page address:
Protocol summary
Study aim
Determining the effects of electrical skin stimulation at acupuncture points PC6, ST36 and LI4 on hemodynamics, pain, nausea and vomiting during general anesthesia in patients requiring elective laparoscopic cholecystectomy
Design
This study is a double - blind randomized clinical trial in phase 3 with two groups of control and intervention that will be conducted on 70 patients need general anesthesia. Random allocation will be done using random letters and computer software.
Settings and conduct
The study is conducted on elective patients who are candidates for general anesthesia in teaching hospitals in Kermanshah. In the intervention group, active electrical stimulation is performed on acupuncture points during the patient's anesthesia. In the control group, electrical stimulation is not performed. Patients and the researcher recording the data are unaware of the grouping and type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who need surgery for cholecystectomy and general anesthesia; reading and writing literacy; verbal ability and healthy vision; healthy skin healthy.
Exclusion criteria: history of smoking and opioids؛ use of analgesics and antiemetic drugs during the past 24 hours; history of diabetes and cardiovascular disease; having a pacemaker.
Intervention groups
In the control group (C), during anesthesia, electrodes are connected bilaterally to acupuncture points in the PC6, ST36, and LI4 areas of the patients, but the stimulation device is inactive and turned off. In the intervention group (I), bilateral electrical stimulation at the aforementioned acupuncture points continues simultaneously from 10 minutes before anesthesia induction until the end of anesthesia and recovery.
Main outcome variables
Blood pressure changes; heart rate changes; pain intensity; amount of analgesia taken; severity of nausea and vomiting
General information
Reason for update
Updating study start and end dates
Acronym
IRCT registration information
IRCT registration number:IRCT20240123060780N4
Registration date:2026-03-16, 1404/12/25
Registration timing:prospective
Last update:2026-07-05, 1405/04/14
Update count:1
Registration date
2026-03-16, 1404/12/25
Registrant information
Name
Rasoul Kavyannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
r.kavyannejad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-21, 1405/01/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
2026-03-22, 1405/01/02
Actual recruitment end date
2026-06-22, 1405/04/01
Trial completion date
2026-06-23, 1405/04/02
Scientific title
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
Public title
Effects of skin electrical stimulation at acupuncture points on hemodynamics, pain, nausea and vomiting during anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 25 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2026-02-22, 1404/12/03
Ethics committee reference number
IR.KUMS.MED.REC.1404.266
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
1
Description
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)
2
Description
Severity of postoperative nausea and vomiting
Timepoint
Within 24 hours after surgery
Method of measurement
Using the Simplified PONV Impact Scale
3
Description
Opioid analgesic dosage
Timepoint
Within 24 hours after surgery
Method of measurement
Dosage in milligrams based on the patient's record
4
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.