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出境医 / 临床实验 / Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty

Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty

Study Description
Brief Summary:
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world.Later acupuncture was introduced to other regions such as Asia, Europe and the United States.The most extensive use of acupuncture is for pain relief.Especially, postoperative nausea and vomiting have been studied.In one study, PC6 (approximately two cm above the midline of the wrist line) showed antiemetic effect, with the addition of other acupuncture points, it proved to have a protective effect in the treatment of postoperative nausea and vomiting.ST36 (Approximately 1-2 cm laterally from the tuberocyte tibia) is an acupuncture point used in the treatment of diseases such as inflammation, acute pain, hypertension and gastrointestinal disorders.

Condition or disease Intervention/treatment Phase
Pain Acupuncture Device: Acupuncture Pres Needle: 0.22x1.5 mm needle Not Applicable

Detailed Description:

Patients will be determined as Group A: Acukupuncture group and Group C as Control group and 35 patients will be included in the study. Both groups will be given an intravenous (i.v) route in the preoperative patient room, PGE2, IL 6 will be taken for blood and 0.09% NaCl will be started. Group A preoperatively, 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the Tibia) to be applied to the press needle (0.22x1.3 mm) and the tape (Needle Press will remain for 24 hours after surgery. Electrocardiography (ECG), noninvasive blood pressure (SBP-DBP), and peripheral arterial oxygen saturation (SpO2) monitoring will be applied to the patients. In the induction of anesthesia, Pentotal 5 mg / kg, Fentanyl 0.5 mcg / kg, and rocuronium 0.6 mg / kg will be used. Anesthesia maintenance will be provided with a 2% concentration of sevoflurane, 50% nitrous oxide (N2O) and 50% oxygen (O2) mixture and appropriately intubated. Patients will be recorded with systolic blood pressure (SBP), diastolic blood pressure (heart failure), heart rate (HR), mean arterial pressure (MAP) and SpO2, 5, 15, 30, 60, 120 minutes (min) after induction.

Patients in Group A and Group C had a saturation value of 97% or more, and exhaled if breathing effort was sufficient. Atropine and neostigmine will be used to neutralize muscle relaxants. Contramal 1mg / kg will be applied to the patients as standard by 20 minutes before the end of surgery. Following the termination of the surgical intervention, the anesthesia gases will be cut and 100% O2 will be inhaled with the mask until all the cases are compiled. 5.dk follow-up and extubation period of the patients will be taken to the postoperative rest room after being followed up on the operating table. 30. Min follow-up will be sent to their services after being done here. Postoperative 60 min, 3 h, 6 h, 12 h, 24 h, sore throat, nausea, vomiting, cough, itching, dysphagia, sore throat and analgesic needs, whether pain, assessment will be made. VAS score will be used to evaluate pain. Paracetamol will be applied to all patients when analgesia needs. At 24 hours postoperatively, blood will be taken to look for PGE2 and IL6 values.Preoperative and postoperative PGE2 and IL 6 values will be compared between the groups of the acupuncture group and the control group.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A: Acupuncture Group Group C: Control Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : April 30, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Acupuncture

Group A: Acupuncture group:Group A: Acupunctur will be applied to the Acupunctur group 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally on the tibia) . The tape (Needle Press) will stay for 24 hours.

Needle Press: Pres Needle: 0.22x1.5 mm needle

 Device: Acupuncture Pres Needle: 0.22x1.5 mm needle
Acupunctur group; Acupunctur preoperatively 24 hours before bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the tuberocyte tibia). The tape (Needle Press) will remain for 24 hours after surgery.
No Intervention: Control Group
Group C: Control group
Outcome Measures
Primary Outcome Measures :
  1. Change Pain Scores [ Time Frame: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation ]
    VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

  2. PG E2 [ Time Frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours ]
    To evaluate the impact on the circulating levels of PG E2 ng/ml

  3. IL 6 [ Time Frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours ]
    To evaluate the impact on the circulating levels of IL 6 ng/ml

  4. Nause and Vomiting [ Time Frame: After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours ]
    Yes or No Nause and vomiting


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after operation ]
    Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,

  2. Heart rate [ Time Frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours ]
    heart rate ,

  3. Change of Itching, cough, sore throat, difficulty in swallowing [ Time Frame: Do Patients have any Itching, cough, sore throat, difficulty in swallowing in 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after operation ]
    it will be asked if there are Itching, cough, sore throat, difficulty in swallowing.more in which group.

  4. oxygen follow-up [ Time Frame: at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during ]
    oxygen saturation

  5. oxygen follow-up [ Time Frame: 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation, ]
    oxygen saturation


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II group
  • Aged 18-75
  • Volunteer to participate in the study
  • Conscious patients.

Exclusion Criteria:

  • Not wanting to participate
  • Unconscious
  • Having a hearing and speech problem
  • Allergic disease and bleeding disorder
  • Respiratory problems
Contacts and Locations

Locations
Layout table for location information
Turkey
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, Turkey, 251/A 46040
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
Layout table for investigator information
Principal Investigator: yavuz orak, md Kahramanmaraş Sutcu Imam University Faculty of Medicine
Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE July 5, 2019
Actual Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Change Pain Scores [ Time Frame: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation ]
    VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
  • PG E2 [ Time Frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours ]
    To evaluate the impact on the circulating levels of PG E2 ng/ml
  • IL 6 [ Time Frame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours ]
    To evaluate the impact on the circulating levels of IL 6 ng/ml
  • Nause and Vomiting [ Time Frame: After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours ]
    Yes or No Nause and vomiting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Blood Pressure [ Time Frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after operation ]
    Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,
  • Heart rate [ Time Frame: During operation at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes and After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours ]
    heart rate ,
  • Change of Itching, cough, sore throat, difficulty in swallowing [ Time Frame: Do Patients have any Itching, cough, sore throat, difficulty in swallowing in 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after operation ]
    it will be asked if there are Itching, cough, sore throat, difficulty in swallowing.more in which group.
  • oxygen follow-up [ Time Frame: at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during ]
    oxygen saturation
  • oxygen follow-up [ Time Frame: 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation, ]
    oxygen saturation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty
Official Title  ICMJE Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study
Brief Summary Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world.Later acupuncture was introduced to other regions such as Asia, Europe and the United States.The most extensive use of acupuncture is for pain relief.Especially, postoperative nausea and vomiting have been studied.In one study, PC6 (approximately two cm above the midline of the wrist line) showed antiemetic effect, with the addition of other acupuncture points, it proved to have a protective effect in the treatment of postoperative nausea and vomiting.ST36 (Approximately 1-2 cm laterally from the tuberocyte tibia) is an acupuncture point used in the treatment of diseases such as inflammation, acute pain, hypertension and gastrointestinal disorders.
Detailed Description

Patients will be determined as Group A: Acukupuncture group and Group C as Control group and 35 patients will be included in the study. Both groups will be given an intravenous (i.v) route in the preoperative patient room, PGE2, IL 6 will be taken for blood and 0.09% NaCl will be started. Group A preoperatively, 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the Tibia) to be applied to the press needle (0.22x1.3 mm) and the tape (Needle Press will remain for 24 hours after surgery. Electrocardiography (ECG), noninvasive blood pressure (SBP-DBP), and peripheral arterial oxygen saturation (SpO2) monitoring will be applied to the patients. In the induction of anesthesia, Pentotal 5 mg / kg, Fentanyl 0.5 mcg / kg, and rocuronium 0.6 mg / kg will be used. Anesthesia maintenance will be provided with a 2% concentration of sevoflurane, 50% nitrous oxide (N2O) and 50% oxygen (O2) mixture and appropriately intubated. Patients will be recorded with systolic blood pressure (SBP), diastolic blood pressure (heart failure), heart rate (HR), mean arterial pressure (MAP) and SpO2, 5, 15, 30, 60, 120 minutes (min) after induction.

Patients in Group A and Group C had a saturation value of 97% or more, and exhaled if breathing effort was sufficient. Atropine and neostigmine will be used to neutralize muscle relaxants. Contramal 1mg / kg will be applied to the patients as standard by 20 minutes before the end of surgery. Following the termination of the surgical intervention, the anesthesia gases will be cut and 100% O2 will be inhaled with the mask until all the cases are compiled. 5.dk follow-up and extubation period of the patients will be taken to the postoperative rest room after being followed up on the operating table. 30. Min follow-up will be sent to their services after being done here. Postoperative 60 min, 3 h, 6 h, 12 h, 24 h, sore throat, nausea, vomiting, cough, itching, dysphagia, sore throat and analgesic needs, whether pain, assessment will be made. VAS score will be used to evaluate pain. Paracetamol will be applied to all patients when analgesia needs. At 24 hours postoperatively, blood will be taken to look for PGE2 and IL6 values.Preoperative and postoperative PGE2 and IL 6 values will be compared between the groups of the acupuncture group and the control group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Group A: Acupuncture Group Group C: Control Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain
  • Acupuncture
Intervention  ICMJE Device: Acupuncture Pres Needle: 0.22x1.5 mm needle
Acupunctur group; Acupunctur preoperatively 24 hours before bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the tuberocyte tibia). The tape (Needle Press) will remain for 24 hours after surgery.
Study Arms  ICMJE
  • Active Comparator: Acupuncture

    Group A: Acupuncture group:Group A: Acupunctur will be applied to the Acupunctur group 24 hours prior to bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally on the tibia) . The tape (Needle Press) will stay for 24 hours.

    Needle Press: Pres Needle: 0.22x1.5 mm needle

    Intervention: Device: Acupuncture Pres Needle: 0.22x1.5 mm needle
  • No Intervention: Control Group
    Group C: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019) 		70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2020
Actual Primary Completion Date April 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I-II group
  • Aged 18-75
  • Volunteer to participate in the study
  • Conscious patients.

Exclusion Criteria:

  • Not wanting to participate
  • Unconscious
  • Having a hearing and speech problem
  • Allergic disease and bleeding disorder
  • Respiratory problems
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009070
Other Study ID Numbers  ICMJE 2018/12-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yavuz Orak, Kahramanmaras Sutcu Imam University
Study Sponsor  ICMJE Kahramanmaras Sutcu Imam University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: yavuz orak, md Kahramanmaraş Sutcu Imam University Faculty of Medicine
PRS Account Kahramanmaras Sutcu Imam University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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