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

Primary Purpose

Pain, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture Pres Needle: 0.22x1.5 mm needle
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kahramanmaras Sutcu Imam University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Acupuncture

Control Group

Arm Description

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

Group C: Control group

Outcomes

Primary Outcome Measures

Change Pain Scores
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
PG E2
To evaluate the impact on the circulating levels of PG E2 ng/ml
IL 6
To evaluate the impact on the circulating levels of IL 6 ng/ml
Nause and Vomiting
Yes or No Nause and vomiting

Secondary Outcome Measures

Blood Pressure
Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,
Heart rate
heart rate ,
Change of Itching, cough, sore throat, difficulty in swallowing
it will be asked if there are Itching, cough, sore throat, difficulty in swallowing.more in which group.
oxygen follow-up
oxygen saturation
oxygen follow-up
oxygen saturation

Full Information

First Posted
March 8, 2019
Last Updated
August 10, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT04009070
Brief Title
Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty
Official Title
Effect of Acupuncture on Nausea, Vomiting, Pain, PGE2 and IL 6 in Septorhinoplasty Operations; Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acupuncture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A: Acupuncture Group Group C: Control Group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Group C: Control group
Intervention Type
Device
Intervention Name(s)
Acupuncture Pres Needle: 0.22x1.5 mm needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Pain Scores
Description
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Time Frame
5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation
Title
PG E2
Description
To evaluate the impact on the circulating levels of PG E2 ng/ml
Time Frame
Change from baseline and concentration of preoperativ and postoperative values at 24.hours
Title
IL 6
Description
To evaluate the impact on the circulating levels of IL 6 ng/ml
Time Frame
Change from baseline and concentration of preoperativ and postoperative values at 24.hours
Title
Nause and Vomiting
Description
Yes or No Nause and vomiting
Time Frame
After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic blood pressue mmHg , diastolic blood pressure mmHg, mean arterial pressure mmHg,
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
Title
Heart rate
Description
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
Title
Change of Itching, cough, sore throat, difficulty in swallowing
Description
it will be asked if there are Itching, cough, sore throat, difficulty in swallowing.more in which group.
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
Title
oxygen follow-up
Description
oxygen saturation
Time Frame
at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during
Title
oxygen follow-up
Description
oxygen saturation
Time Frame
30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yavuz orak, md
Organizational Affiliation
Kahramanmaraş Sutcu Imam University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Faculty of Medicine
City
Kahramanmaraş
State/Province
Onikişubat
ZIP/Postal Code
251/A 46040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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