Treatment Complication Clinical Trial
Official title:
Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
NCT number | NCT04748133 |
Other study ID # | 6658 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 20, 2021 |
Est. completion date | July 1, 2021 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig University | Zagazig |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
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 |
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