The Preventive effectiveness of dry cupping on Post Operative Nausea and Vomiting (PONV) through P6 Acupoint Stimulation; a Randomized Controlled Trial
(1) Background and Introduction: Post Operative Nausea and Vomiting (PONV) is a common complication of anesthesia and surgery in thirty percent cases under general anesthesia is a significant event. Some Complementary & Alternative medicine (CAM) methods were effect on the P6 point in controlling nausea and vomiting. (2) Objectives: Determines the effects of Dry Cupping on prevention of PONV through the stimulation of point P6. (3) Design: Randomized Controlled Trial. (4) Setting and conduct: Study conduct on laparoscopic patients admitted in surgery ward of Imam Reza (AS) Hospital in Kermanshah city. In both groups after the prescript of premedication, ( midazolam ten minutes before induction of anesthesia), Cup will put on point P6 in dominant hand. In "experimental group" the negative pressure will activated but in "control group (Sham group)" the negative pressure will be inactive. (5) Participants including major eligibility criteria: Total sample size is two hundred and twelve patients .The sample size is one hundred and six patients for each groups ("experimental group" and "control group").Inclusion criteria Studies using Apfel including: female gender; age over eighteen years; ASA Class I-III; type of surgery laparoscopic cholecystectomy; type of anesthesia General Anesthesia. Exclusion criteria: change the type of surgery (to Laparotomy); ASA Class more than three. (6) Interventions: In intervention group will be received dry cupping on point P6 in dominant hand with activation of negative pressure during operation and twenty hours postoperative. The control group will be received dry cupping on point P6 in dominant hand without activation of negative pressure during operation and twenty hours postoperative. (7) Main outcome measures (variables): The severity of nausea and vomiting after surgery will be measured by Visual analogue Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102011310N6
Registration date:2011-02-24, 1389/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Preventive effectiveness of dry cupping on Post Operative Nausea and Vomiting (PONV) through P6 Acupoint Stimulation; a Randomized Controlled Trial
Public title
The Preventive effectiveness of dry cupping on Post Operative Nausea and Vomiting (PONV) through P6 Acupoint Stimulation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria Studies using Apfel including: female gender; age over eighteen years; ASA Class I-III; type of surgery laparoscopic cholecystectomy; type of anesthesia General Anesthesia
Exclusion criteria: change the type of surgery (to Laparotomy); ASA Class more than three.
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Science
Street address
Building no 2, Shahid Beheshti Boulevard, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
67188
Approval date
2011-01-15, 1389/10/25
Ethics committee reference number
1800459
Health conditions studied
1
Description of health condition studied
Vomiting following gastrointestinal surgery
ICD-10 code
K91.0
ICD-10 code description
استفراغ بعد از جراحی دستگاه گوارش
Primary outcomes
1
Description
Post Operative Nausea and Vomiting (PONV) Post Operative Nausea and Vomiting (PONV)
Timepoint
In three stages: Two hours Post Operative, 2. Six hours Post Operative, 3. Twenty four hours Post Operative
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
The risk of PONV
Timepoint
Before starting of study
Method of measurement
(ARD) Absolute Risk Deference
2
Description
Prescription of anti-vomiting drugs
Timepoint
In three stages: Two hours Post Operative, 2. Six hours Post Operative, 3. Twenty four hours Post Operative
Method of measurement
NNT (Numbers Need to Treat)
Intervention groups
1
Description
Intervention group: Dry Cupping on point P6 in dominant hand with activation of negative pressure.
Category
Treatment - Other
2
Description
Control group: Dry Cupping on point P6 in dominant hand without activation of negative pressure.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Hospital, Kermanshah
Full name of responsible person
Khosro Farhadi, MD
Street address
Imam Reza (AS) Hospital, Parastar Boulvard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences,Shahid Beheshti Boulevard,
City
Kermanshah
Grant name
------------------
Grant code / Reference number
-----------------------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Khosro Farhadi, MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Reza (AS) Hospital, Parastar Boulvard, Kermanshah University of Medical Sciences