Objectives: To comparison of the effect of acupuncture and metoclopramide on postoperative nausea and vomiting after gynecological laparoscopy. Design: a double blinded randomized clinical trial. Setting and conduct: All eligible women patients who was candidate for laparoscopy and referred to the Imam Khomini Hospital during the study period enrolled in to the trial. Inclusion criteria: (a) candidate for Gynecological Laparoscopy; (b) age of 19 to 46 years. Exclusion criteria: (a) smoking; (b) motion sickness; (c) antiemetic medications 24 hours prior to surgery; (d) presence of scar or infection at site of needling on wrist or elbow; (e) history of gastrointestinal disorder or ear diseases that may lead to nausea or vomiting; (f) prolongation of surgery longer than two hours. Intervention: Performing acupuncture through inserting special needle at point of P6 in front of the elbow immediately after anesthesia and removing it before intubation and transferring the patient to the recovery room. Control: Prescribing single dose of metoclopramide 0.2 mg/kg intravenously before intubation and transferring the patient to the recovery room. Primary outcome: Assessing the number of times nausea and vomiting occur during the period that the patient stays in recovery room through question or clinical observation. Secondary outcome: local reaction at site of acupuncture needle during the period that the patient stays in recovery room through clinical examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012217268N4
Registration date:2017-01-30, 1395/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Vahid Saidkhani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1321 9101
Email address
v.saidkhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2007-07-08, 1386/04/17
Expected recruitment end date
2008-01-07, 1386/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupuncture and metoclopramide on the postoperative nausea and vomiting in gynecological laparoscopy
Public title
Comparison of the effect of acupuncture and metoclopramide on the postoperative nausea and vomiting in gynecological laparoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) candidate for gynecological laparoscopy; (b) age of 19 to 46 years. Exclusion criteria: (a) smoking; (b) motion sickness; (c) antiemetic medications 24 hours prior to surgery; (d) presence of scar or infection at site of needling on wrist or elbow; (e) history of gastrointestinal disorder or ear diseases that may lead to nausea or vomiting; (f) prolongation of surgery longer than two hours.
Age
From 19 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz. Highway Golestan, Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2007-07-07, 1386/04/16
Ethics committee reference number
p/8/20/3664
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
number of times vomiting occur
Timepoint
during the period that the patient stays in recovery room and ward
Method of measurement
through question and clinical observation
Secondary outcomes
1
Description
local reaction at site of acupuncture needle
Timepoint
during the period that the patient stays in recovery room
Method of measurement
through clinical examination
Intervention groups
1
Description
Intervention Group : Performing acupuncture through inserting special needle at point of P6 in front of the elbow immediately after anesthesia and removing it before intubation and transferring the patient to the recovery room.
Category
Treatment - Other
2
Description
Control Group : Prescribing single dose of metoclopramide 0.2 mg intravenously before intubation and transferring the patient to the recovery room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomani Hospital
Full name of responsible person
Masoumeh Alboghobish
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoomeh Alboghobeish
Position
MSc of Anesthesiology, Faculty Member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, School of paramedicine
City
Ahvaz
Postal code
Phone
+98 61 3373 8285
Fax
Email
ghobeish@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoomeh Alboghobeish
Position
MSc of Anesthesiology, Faculty Member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, School of paramedicine
City
Ahvaz
Postal code
Phone
+98 61 3373 8285
Fax
Email
ghobeish@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Vahid Saidkhani
Position
MSc of Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, School of paramedicine
City
Ahvaz
Postal code
Phone
+98 61 3373 8285
Fax
Email
v.saidkhani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)