Clinical trial NCT04009070: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Acupuncture
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Acupuncture Group Group C: Control Group
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change Pain Scores
timeFrame: 5 minute,30 minute, 60 minute, 3 hours, 6 hours, 12 hours, 24 hours after the operation
measure: PG E2
timeFrame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
measure: IL 6
timeFrame: Change from baseline and concentration of preoperativ and postoperative values at 24.hours
measure: Nause and Vomiting
timeFrame: After operation at 5 minutes, 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes:
measure: Blood Pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Change of Itching, cough, sore throat, difficulty in swallowing
timeFrame: 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
measure: oxygen follow-up
timeFrame: at 5 minute, 15 minutes, 30 minutes, 60 minutes, 120 minutes during
measure: oxygen follow-up
timeFrame: 30 minutes, 60 minutes,3 hours, 6 hours, 12 hours, 24 hours after the operation,
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University Faculty of Medicine
state: Onikişubat
Study officials:
affiliation: Kahramanmaraş Sutcu Imam University Faculty of Medicine
name: yavuz orak, md
role: PRINCIPAL_INVESTIGATOR
References: