The study, which is triple-blind clinical trial to evaluate the effect of nicotine patch on the nausea and vomiting and pain after the surgery is performed. Patients between the ages of 18 and 65 and non-smokers will be included in the study. The population studied was all patients undergoing laparoscopic cholecystectomy. The sample size included 100 patients. Patients were randomly divided into two groups of 50 people will be treated with medication and placebo. One hour prior to the operation, the nicotine patch and placebo was installed for 24 hours and the pain and nausea and vomiting of the patients will be recorded at 1, 6, 12 and 24 hours. Patients' pain will be assessed with a visual analogue scale and to measure nausea and vomiting Checklist will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092336328N1
Registration date:2017-10-04, 1396/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Sajjad Dindar
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 0771
Email address
s.dindar@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Ardabil University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nicotine patch on reduction of nausea and vomiting and pain following bile duct surgery using laparoscopic method
Public title
The effect of nicotine patch on reducing nausea and vomiting and postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 65 years of age ; Non-smoking patients ; Not having a history of heart disease and nervous disorders, diabetes and hypertension
Exclusion criteria: Patients with scores of pain above 8 on the basis of pain assessment criteria ; Receiving an additional pain reliever for pain control ; Patients requiring laparotomy ; Patients unable to maintain a nicotine pach for 24 hour
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil - Kowsar Town - Central Office of Ardabil University of Medical Sciences
City
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
Ir.Arums.rec.1396.82
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
2
Description of health condition studied
Postoperative pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Pain
Timepoint
1st, 6th, 12th and 24th hours after surgery
Method of measurement
Visual Scale of Pain
2
Description
nausea and vomiting
Timepoint
1st, 6th, 12th and 24th hours after surgery
Method of measurement
Nausea and vomiting evaluation checklist
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group labels containing 17.5 mg nicotine for 24 hours, were made in England
Category
Treatment - Drugs
2
Description
In the control group, the drug-free labels of Osveh Company were used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ardebil
Full name of responsible person
Ali Ali mohamadi
Street address
Ardebil , Ataee Street , Imam Khomeini Hospital
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahrah Habibzadeh
Street address
Ardabil, Daneshgah st. Ardabil Complex University, Deputy Research and Technology
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Mir salim Seyed sadeghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Sarein Station, Imam Khomeini Street, not reaching Shariati Square, Fatemi Educational and Therapeutic Center
City
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
Email
fatemi@arums.ac.ir s.seyedsadegi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Khatereh Isazade far
Position
Assistant Professor
Other areas of specialty/work
Street address
Ardebil, Janbazan Square, University Street End, above University Square, Faculty of Medicine and Paramedicine