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

Primary Purpose

Treatment Complication

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
acupuncture needles
placebo
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Complication

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

acupuncture

placebo

Arm 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.

no treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

extubation time
time from discontinuation of isoflurane to extubation
recovery time
time from discontinuation of isoflurane to first response to verbal command
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
The total number of rescue antiemetic (metoclopramide)
Any patient will receive 10 mg intravenous metoclopramide immediately if there is nausea and vomiting
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
number of participant with side effects of acupuncture
bleeding, soreness, or bruising at the site of needle insertion

Full Information

First Posted
February 8, 2021
Last Updated
February 22, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04748133
Brief Title
Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries
Official Title
Acupuncture for Enhancing Recovery and Attenuating Postoperative Nausea and Vomiting After Middle Ear Surgeries: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
no treatment
Intervention Type
Device
Intervention Name(s)
acupuncture needles
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
no treatment
Primary Outcome Measure Information:
Title
incidence of postoperative nausea and vomiting
Description
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
Time Frame
up to 24 hours postoperative
Secondary Outcome Measure Information:
Title
extubation time
Description
time from discontinuation of isoflurane to extubation
Time Frame
up to 10 minutes postoperative
Title
recovery time
Description
time from discontinuation of isoflurane to first response to verbal command
Time Frame
up to 30 minutes postoperative
Title
The time of discharge
Description
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
Time Frame
up to 30 minutes postoperative
Title
The total number of rescue antiemetic (metoclopramide)
Description
Any patient will receive 10 mg intravenous metoclopramide immediately if there is nausea and vomiting
Time Frame
in the first 24 hour postoperative
Title
Postoperative Pain
Description
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
Time Frame
up to 30 minutes, 2 hours and 4 hours postoperative
Title
number of participant with side effects of acupuncture
Description
bleeding, soreness, or bruising at the site of needle insertion
Time Frame
up to 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Zakzouk, MD
Phone
01004178761
Ext
002
Email
dr.marwa.zu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Al shaimaa Kamel, MD
Phone
01005593169
Ext
002
Email
AlshaimaaKamel80@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Zakzouk, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwa Zakzouk, MD
Phone
01004178761
Ext
002
Email
dr.marwa.zu@gmail.com
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel
Phone
01005593169
Email
Alshaimaakamel80@yahoo.com

12. IPD Sharing Statement

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

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