The influence of oral Ginger before operation on nausea and vomiting after cataract surgery under general anesthesia: A double-blind placebo-controlled randomized clinical trial.
This study is conducted in order to determinate the influence of ginger orally on pain, nausea and vomiting after cataract surgery under general anesthesia. The study is done in Phase II clinical trials and single-center, double-blind. The study population is volunteer’s cataract surgery patients in Tohid Hospital in Sanandaj. Based on inclusion criteria and attrition rate 129 participants are Purposefully selected. Randomization will be done using sealed envelopes and Participants are randomly allocated into two interventions and one placebo-control groups. Inclusion criteria included; surgical candidates; volunteered to participate in the study; lack of underlying chronic medical conditions; lack of nausea and vomiting; under general anesthetic with a specific drug. Exclusion criteria included cancel surgery, Patient’s withdrawal from the research, cancel surgery and unpredicted events during surgery such as cardiac arrest or patient’s death. In the first intervention group, the patients were given two capsules each of them 500 mg ginger at 6 a.m. before the operation. As of the second group, they were given two capsules each of them 500 mg ginger at 10 p.m. and 6 a.m. before the operation. In the control group, they were given a placebo capsule similar to capsules each of them 500 mg ginger at 6 a.m. before the operation. Based on Visual Analog Scale (VAS) as standard tool; severity of pain and nausea are recorded from zero to ten up to six hours after surgery. Incidences of pain, nausea and vomiting are recorded in the information sheet.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062122853N1
Registration date:2016-08-18, 1395/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Simin Nazarian
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4645
Email address
nazarian.simin@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2015-06-15, 1394/03/25
Expected recruitment end date
2016-03-18, 1394/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of oral Ginger before operation on nausea and vomiting after cataract surgery under general anesthesia: A double-blind placebo-controlled randomized clinical trial.
Public title
The influence of oral Ginger on nausea and vomiting after cataract surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included; surgical candidates; volunteered to participate in the study; lack of underlying medical conditions (diabetes, chronic respiratory disease, chronic heart disease, kidney disorders, liver kidney disorders, kidney disorders, dementia, Alzheimer's disease and other acute or chronic disorders);Lack of preoperative nausea and vomiting; is to using general anesthesia with a specific drugs including propofol or thiopental.
Exclusion criteria included Patient’s withdrawal from the research, cancel surgery, and unpredicted events during surgery such as cardiac arrest or patient’s death
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done using sealed envelopes
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj, postal code:13446-66177
City
Sanandaj
Postal code
6617713446
Approval date
2015-01-19, 1393/10/29
Ethics committee reference number
IR.MUK.REC.93.132
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H25.9
ICD-10 code description
Combined forms of senile cataract
Primary outcomes
1
Description
Pain
Timepoint
From the moment of admission to recovery up to six hours after surgery. At the moment of admission to the ward after surgery and at 2, 4, and 6 hours after admission to the ward.
Method of measurement
Incidences of pain are recorded in the information sheet. Based on Visual Analog Scale (VAS) as standard tool; severity of pain is rated from zero to ten.
2
Description
nausea
Timepoint
From the moment of admission to recovery up to six hours after surgery. At the moment of admission to the ward after surgery and at 2, 4, and 6 hours after admission to the ward.
Method of measurement
Incidences of nausea are recorded in the information sheet. Based on Visual Analog Scale (VAS) as standard tool; severity of nausea is rated from zero to ten.
3
Description
vomiting
Timepoint
From the moment of admission to recovery up to six hours after surgery. At the moment of admission to the ward after surgery and at 2, 4, and 6 hours after admission to the ward.
Method of measurement
Incidence of vomiting is recorded in the information sheet.
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 2: the patients were given two capsules each of them 500 mg ginger at 10 p.m. and 6 a.m. before the operation.
Category
Treatment - Drugs
2
Description
Control group: the patients were given a placebo capsule similar to capsules each of them 500 mg ginger at 6 a.m. before the operation.
Category
Treatment - Drugs
3
Description
intervention group1: the patients were given two capsules each of them 500 mg ginger at 6 a.m. before the operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Simin Nazarian
Street address
Tohid Hospital, Tohid Street, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaee
Street address
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446
City
Sanandaj
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 and technology of Kurdistan 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
Kurdistan University of medical sciences
Full name of responsible person
Simin Nazarian
Position
Faculty member/MS.C
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3182 7474
Fax
+98 87 3366 0092
Email
Sara_nazarian@yahoo.comNazarian.simin@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
ph.D/Assistant professor
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3182 7464
Fax
+98 87 3366 0092
Email
jamal.seidi@yahoo.ccom
jamal.seidi@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Assistant professor/ph.D
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3182 7464
Fax
+98 87 3366 0092
Email
jamal.seidi@yahoo.com
jamal.seidi@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)