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

Zagazig University

Status: Unknown

Conditions: Treatment Complication

Treatments: Other: placebo; Device: acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT04748133

6658

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups, including a placebo group

acupuncture

Active Comparator group

Description:

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.

Treatment:

Device: acupuncture needles

placebo

Placebo Comparator group

Description:

no treatment

Treatment:

Other: placebo