Treatment ComplicationNCT04748133
Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries
A study testing acupuncture needles in people with Treatment Complication, run by Zagazig University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Complication
- What is being tested?
- acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig
Marwa Zakzouk, MD, 01004178761 ext. 002, dr.marwa.zu@gmail.com
Alshaimaa Kamel, 01005593169, Alshaimaakamel80@yahoo.com
About this study
Official title: Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Treatment Complication
- Being tested
- acupuncture needles, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture needlesDevice
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
placeboOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: acupuncture needles |
| placebo | Placebo comparator | no treatment Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 hours postoperative
Secondary outcomes (6)
extubation time
time from discontinuation of isoflurane to extubation
Measured: up to 10 minutes postoperative
recovery time
time from discontinuation of isoflurane to first response to verbal command
Measured: 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
- 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Feb 2021
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment ComplicationStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mahmoud Abd Allah Zakzouk, Zagazig University
- Investigators
- Marwa Zakzouk, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748133
- Sponsor's protocol ID
- 6658
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04748133
- Acronym / sponsor ID
- 6658
- Conditions
- Treatment Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Active comparator | Device: acupuncture needlesPatients 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 | Other: placebono treatment |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture needlesSite 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 | Device | acupuncture |
| placebono treatment | Other | placebo |
Primary outcome
incidence of postoperative nausea and vomiting
Time frame: up to 24 hours postoperative
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
6 secondary outcomes
extubation time
Time frame: up to 10 minutes postoperative
recovery time
Time frame: up to 30 minutes postoperative
The time of discharge
Time frame: up to 30 minutes postoperative
The total number of rescue antiemetic (metoclopramide)
Time frame: in the first 24 hour postoperative
Postoperative Pain
Time frame: up to 30 minutes, 2 hours and 4 hours postoperative
number of participant with side effects of acupuncture
Time frame: up to 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Zakzouk, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture needles in people with Treatment Complication, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Zakzouk, MD (01004178761 ext. 002, dr.marwa.zu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative nausea and vomiting (time frame: up to 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.