Comparison between effects of oral Lorazepam with placebo in decreasing nausea and vomiting after laparoscopic cholecystectomy under general anesthesia
Aim: The purpose of this study was to compare the effect of oral lorazepam with placebo in reducing nausea and vomiting in patients undergoing laparoscopic cholecystectomy after general anesthesia. This study design with simple random sampling and double blind on 76 patients with ASA I- II undergoing laparoscopic cholecystectomy will be done .After the patients were selected based on inclusion: Age: 20-60 years, B MI<30, Duration of surgery <1 hour, ASA: I- II and exclusion criteria: Hemodynamic effect after administration of lorazepam, Anti emetic medication before surgery , Systolic blood pressure less than 90 mm Hg or greater than 160 mm Hg, History of drug abuse and tricyclic antidepressants ; were randomly placed in two groups . One milligram lorazepam pill with 10 mL of water will be given in treatment group and the control group given a placebo pill, 60 minutes before surgery. Primary outcomes: Post operative nausea and vomiting. Secondary outcome: Satisfaction of patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051917742N2
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
Fatemeh Javaherforoosh Zadeh
Name of organization / entity
Ahvaz Joundishapoor University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 9315
Email address
javaherforosh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research o f Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-22, 1395/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effects of oral Lorazepam with placebo in decreasing nausea and vomiting after laparoscopic cholecystectomy under general anesthesia
Public title
Lorazepam effect on reducing nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :Age: 20-60 years, B MI<30, Duration of surgery <1 hour, ASA: I- II
Exclusion criteria: Hemodynamic effect after administration of lorazepam, Anti emetic medication before surgery , Systolic blood pressure less than 90 mmHg or greater than 160 mmHg, History of drug abuse and tricyclic antidepressants
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan street,Ahvaz
City
Ahvaz
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
B-9370 :کد ثبت , ajums.REC.1394.3
Health conditions studied
1
Description of health condition studied
Hyperemesis gravidarum
ICD-10 code
O21.1
ICD-10 code description
Hyperemesis gravidarum with metabolic disturbance
Primary outcomes
1
Description
nausea
Timepoint
0,6,24 hiurs after surgery
Method of measurement
visual analog scale
2
Description
vomiting
Timepoint
0,6,24 hiurs after surgery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Satisfaction
Timepoint
0,6,24 hours after surgery
Method of measurement
Likert scale
Intervention groups
1
Description
Administration of lorazepam 1 mg 60 minutes before surgery in treatment group
Category
Prevention
2
Description
Administration of placebo tab 60 minutes before surgery in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Street address
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 Nader Saki
Street address
Imam Khomini Hospital-Azadegan street
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, Ahvaz, Iran
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Associate professor of Anesthesia
Other areas of specialty/work
Street address
Imam Khomini Hospital,Azadegan street
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
f_javaherforoosh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Associate professor of Anesthesia
Other areas of specialty/work
Street address
Imam Khomini Hospital,Azadegan street
City
Ahvaz
Postal code
Phone
+98 61 3333 3050
Fax
Email
f_javaherforoosh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr Fatemeh Javaherforoosh Zadeh
Position
Associate professor of Anesthesia
Other areas of specialty/work
Street address
Imam Khomini Hospital,Azadegan street
City
Ahvaz
Postal code
Phone
Fax
Email
f_ javaherforoosh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)