Effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy: a double blinded randomized clinical trial
Objectives: To assess the effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy.
Design: a double blinded randomized clinical trial.
Setting and conduct: All eligible patients who are candidate for elective laparotomy or cholecystectomy and will refer to the Beasat Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a); candidate for elective laparotomy or cholecystectomy; (b) age of 12 to 70 years.
Exclusion criteria: (a) narcotic abuse; (b) alcohol abuse; (c) history of neurological or psychological diseases; (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 10 mg intravenously and single dose of dexamethasone 10 mg 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:IRCT201403039014N29
Registration date:2014-03-11, 1392/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-11, 1392/12/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy: a double blinded randomized clinical trial
Public title
Effect of acupuncture versus metoclopramide on postoperative nausea and vomiting after laparotomy and cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a); candidate for elective laparotomy or cholecystectomy; (b) age of 12 to 70 years.
Exclusion criteria: (a) narcotic abuse; (b) alcohol abuse; (c) history of neurological or psychological diseases; (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 12 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control group using tossing coin.
Blinding: Although informed consent will be taken from all volunteers, however all interventions including acupuncture and injection of metoclopramide and dexamethasone will be done during anesthesia. Thus the patients are unconscious and will be unaware of the intervention. In addition, the physician, who conduct the intervention is different from the physician who will examine the patients and the examiner will not be aware of the intervention. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2013-09-10, 1392/06/19
Ethics committee reference number
D/P/16/35/9/1687
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
number of times nausea and vomiting occur
Timepoint
during the period that the patient stays in recovery room
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
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 - Drugs
2
Description
Prescribing single dose of metoclopramide 10 mg intravenously and single dose of dexamethasone 10 mg intravenously before intubation and transferring the patient to the recovery room.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Dr Shahpour Shoja
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Beasat Hospital
Full name of responsible person
Dr Shahpour Shoja
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1341 6392
Fax
Email
shshoja@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat Hospital
Full name of responsible person
Dr Ebrahim Khoshraftar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Postal code
Phone
+98 81 1341 6392
Fax
Email
khoshraftar@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)