Clinical trial comparing the P6 point stimulation and lack of stimulation in the treatment of nausea and vomiting in patients after laparoscopic cholecystectomy
Objectives: Effects of P6 stimulation on post-operative nausea and vomiting,
Design: Randomized double-blind clinical trial
Setting and conduct: After induction of anesthesia before the surgery is performed acupuncture. Patients were randomized using a random number table in two groups (each group 65 patients). In Group A at the point p6 under sterile conditions with a disposable needle in Group B for at least 15 minutes and no action was taken. After the surgery the patient's spontaneous breathing and level of consciousness is normal and there by trained personnel using visual criteria, the incidence of nausea and vomiting, patients at hours 1, 2 and 4 is recorded after surgery.
Participants including: patients undergo laparoscopic cholecystectomy
Inclusion criteria: Age between 18 to 80; ASA class I and II
Exclusion criteria: Coagulopathies; ulceration; edema and fracture at the site of stimulation
Intervention: P6 point of acupuncture in the treatment group and the control group did not do anything.
Main outcome measures (variables): Nausea and vomiting after surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110224799N2
Registration date:2016-06-12, 1395/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Masoud Saghafinia
Name of organization / entity
Baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3207
Email address
dr_saghafi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2005-07-23, 1384/05/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the P6 point stimulation and lack of stimulation in the treatment of nausea and vomiting in patients after laparoscopic cholecystectomy
Public title
Effects of P6 stimulation on post-operative nausea and vomiting in laparoscopic cholecystectomy patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Age between 18 to 80; ASA class I and II
exclusion criteria: Coagulopathies; ulceration; edema; fracture at the site of stimulation
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra St, Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
Ir.bmsu.rec.1394.155
Health conditions studied
1
Description of health condition studied
postoperative nasuea and vomiting
ICD-10 code
k91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Postperative nausea
Timepoint
After awake in 1, 2 and 4 hours
Method of measurement
According to VAS scale from 0 to 10
Secondary outcomes
1
Description
Vomiting after surgery
Timepoint
After awake in 1, 2 and 4 hours
Method of measurement
Severity of vomiting (mild, moderate, sever)
Intervention groups
1
Description
Intervention 1: at the point p6 under sterile conditions with disposable needles for at least 15 minutes and bran is not important
Category
Prevention
2
Description
Intervention 2: Not applicable
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery departemant of Baqiyatallah university of medical sciences
Full name of responsible person
Majid Amini
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh, St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Amini
Street address
Postal code: 1435917541, Mollasadra St, Sheikh Bahaee, St, Tehran
City
Tehran
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, Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Amini
Position
Student/Anesthesiology resident
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra St, Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 2680 0103
Fax
Email
amini_m1350@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Hassan Araghizadeh
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra Stو Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Phone
+98 21 2680 0103
Fax
Email
amini_m1350@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Majid Amini
Position
Student/Anesthesia resident
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra St, Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
Phone
+98 21 2680 0103
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)