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

NCT04748133 | Unknown

• 1 other identifier: 6658
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• extubation time

  up to 10 minutes postoperative

• recovery time

  up to 30 minutes postoperative

• The time of discharge

  up to 30 minutes postoperative

• The total number of rescue antiemetic (metoclopramide)

  in the first 24 hour postoperative

• Postoperative Pain

  up to 30 minutes, 2 hours and 4 hours postoperative

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

Patients in the acupuncture group will receive a standardised treatment with 12 needles (sharp tip, stainless steel needles, size 0.3 X 40 mm) at 7 acupuncture points Du 26 and Ren 17 (on the middle body line), and bilateral LI 4, HE 7, LV 3, ST 36 and PC 6). Application of the needles is performed by a licensed medical acupuncturist. The needles will be inserted after endotracheal intubation and mechanical ventilation and will be removed immediately before patient extubation.

Device: acupuncture needles

placebo

PLACEBO COMPARATOR

no treatment

Other: placebo

Interventions

acupuncture needles DEVICE

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

acupuncture

placebo OTHER

no treatment

placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Egypt

RECRUITING

Study Officials

• Marwa Zakzouk, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Zakzouk, MD

CONTACT

01004178761; dr.marwa.zu@gmail.com

Al shaimaa Kamel, MD

CONTACT

01005593169; AlshaimaaKamel80@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia & Surgical Intensive Care, Zagazig University

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 10, 2021
• Study Start: February 20, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

EG (1)