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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| placebo | Placebo Comparator | no treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture needles | Device | Site of acupuncture points:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| extubation time | time from discontinuation of isoflurane to extubation | up to 10 minutes postoperative |
| recovery time | time from discontinuation of isoflurane to first response to verbal command |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Zakzouk, MD | Contact | 01004178761 | 002 | dr.marwa.zu@gmail.com |
| Al shaimaa Kamel, MD | Contact | 01005593169 | 002 | AlshaimaaKamel80@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Marwa Zakzouk, MD | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University | Recruiting | Zagazig | Egypt |
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|
| placebo | Other | no treatment |
|
| up to 30 minutes postoperative |
| 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
Patient having a score of 9 or higher is discharged | up to 30 minutes postoperative |
| 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 |
| 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 |
| number of participant with side effects of acupuncture | bleeding, soreness, or bruising at the site of needle insertion | up to 24 hours postoperative |