Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries

Treatment Complication Clinical Trial

Official title:

Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748133
• Other study ID #: 6658
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: February 2021
• Source: Zagazig University
• Contact: Marwa Zakzouk, MD
• Phone: 01004178761
• Email: dr.marwa.zu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Modern surgery management needs increasing operating room turnover and more ambulatory surgery. In order to come over this challenge, the recovery needs to be optimized. Enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. Middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.

Description:

Sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). Sample is calculated using open epi program with confidence level 95% and power 80%. Patients in Group C (control group) (n=29): will receive no treatment. While patients in Group A (Acupuncture group) (n=29): will receive needle acupuncture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Written informed consent from the patient.
• Age: 21-60 years old.
• Sex: both sex (males or females).
• Physical status: ASA 1& II.
• BMI = (20-30 kg/m2).
• Type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy.

Exclusion Criteria:

• Altered mental state
• Patients with Drug abuse or alcohol.
• Patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery.
• Patients with pre-treatment with acupuncture or trigger point injection.
• Pregnancy.

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Treatment Complication
• Vomiting

Intervention

Device:
• acupuncture needles
Site of acupuncture points: Du 26: At junction of the upper and middle third of philtrum. Ren 17: On the midline level with the 4th intercostal space midway between the nipples. LI4 (Large Intestine 4): On the dorsum of the hand, between the 1st and 2nd metacarpal bones HT7 (Heart 7): On the ulnar end of the transverse crease of the wrist, in the small depression between the pisiform and ulna bones LV3 (Liver 3): On dorsum of the foot in a depression distal to the junction of the 1st and 2nd metatarsal bones. ST36 (Stomach 36): Antero-lateral leg, 1 middle-finger breadth next to the anterior crest of tibia, 3 cun under the depression lateral to the patellar ligament. PC6 (Pericardium 6): Palmar aspect of the forearm, between the tendons, 2 cun away from the transverse crease of the wrist

Other:
• placebo
no treatment

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative nausea and vomiting	Postoperative nausea and vomiting impact scale score . Questions Answers score Did you have vomiting or dry retching? No 0 Once 1 Twice 2 Three or more times 3; Have you experienced a feeling of nausea? If yes, has it interfered with your daily activities? Not at all 0 Sometimes 1 Often/most of the times 2 All the time 3; Summation of numerical answer to question 1 plus 2 equal the PONV impact scale. PONV Impact Scale Score of =5 represents clinically important PONV	up to 24 hours postoperative
Secondary	extubation time	time from discontinuation of isoflurane to extubation	up to 10 minutes postoperative
Secondary	recovery time	time from discontinuation of isoflurane to first response to verbal command	up to 30 minutes postoperative
Secondary	The time of discharge	The time from arrival to PACU to discharge to the ward) according to Modified Aldert score Modified Aldert score . Assessment item Condition Grade Activity, able to move, voluntarily or on command 4 extremities 2 2 extremities 1 No 0; Breathing Able to breathe deeply & cough freely 2 Dyspnea, shallow or limited breathing 1 Apnea 0 Consciousness Fully awake 2 Arousable on calling 1 Unresponsive 0; Circulation (blood pressure) ±20% of pre-anesthesia level 2; 20% to 49% of pre-anesthesia level 1; 50% of pre-anesthesia level 0 SPO2 Maintain SPO2 >92% in ambient air 2 Maintain SPO2 >90% with O2 1 Maintain SPO2 <90% with O2 0; Patient having a score of 9 or higher is discharged	up to 30 minutes postoperative
Secondary	The total number of rescue antiemetic (metoclopramide)	Any patient will receive 10 mg intravenous metoclopramide immediately if there is nausea and vomiting	in the first 24 hour postoperative
Secondary	Postoperative Pain	Visual Analogue Scale (VAS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. IV paracetamol 1 gm every 6hs as a protocol for pain management and IV pethidine 30 mg as rescue analgesic will be given if VAS = 4. Total doses and number of analgesics will be recorded	up to 30 minutes, 2 hours and 4 hours postoperative
Secondary	number of participant with side effects of acupuncture	bleeding, soreness, or bruising at the site of needle insertion	up to 24 hours postoperative