Determination of effective dose of Dexamethasone and Promethazine in prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic anti-obesity operation: a clinical Trial.
Objectives: Determination of effective dose of Dexamethasone and Promethasine in prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic anti-obesity operation.
Design: In a post marketing phase of clinical trial (phase 3) or therapeutic uses 64 patients randomly divided into two groups.
Inclusion/exclusion criteria: patients undergoing laparoscopic anti-obesity operation in Sina hospital (single center) with no contra-indication of receiving Dexamethasone and Promethasine.
After induction of anesthesia, first group will receive 50 mg IV promethazin and 8 mg IV Dexamethasone and the second group will receive 25 mg IV promethazine and 4 mg IV Dexamethasone. Patients are asked about nausea severity and vomiting numbers every 12 hours for 48 hours after surgery, by other physicians who will be unaware about the group allocation. Primary and secondary outcome variables: the frequency of vomiting and nausea severity. (Based on VAS indicators will be asked from one to ten.)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510083773N15
Registration date:2016-09-20, 1395/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-20, 1395/06/30
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of effective dose of Dexamethasone and Promethazine in prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic anti-obesity operation: a clinical Trial.
Public title
Prophylaxis of post-operative nausea and vomiting after laparoscopic anti-obesity operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients from ASA class 1 and 2; Patients who are undergoing anti-obesity operation; Age in the range of 15-60 years.
Exclusion criteria: Contraindications to receiving dexamethasone and promethazine; Uncontrolled diabetes or hypertension; Patients who have received anti-emetic drug in 24 hours ago.
Age
From 15 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ِEthics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Enqelab Street
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1394.856
Health conditions studied
1
Description of health condition studied
Prophylaxis of post-operative nausea and vomiting after laparoscopic anti-obesity operation
ICD-10 code
K91.1
ICD-10 code description
Postgastric surgery syndromes
Primary outcomes
1
Description
postoperative Nausea
Timepoint
12 hours after operation & 48 hours after operation
Method of measurement
Visual Analogue Scale
2
Description
postoperative vomiting
Timepoint
12 hours after operation & 48 hours after operation
Method of measurement
number
Secondary outcomes
empty
Intervention groups
1
Description
After induction of anesthesia, first group will receive 50 mg IV promethazine and 8 mg IV Dexamethasone
Category
Treatment - Drugs
2
Description
After induction of anesthesia, the second group will receive 25 mg IV promethazine and 4 mg IV Dexamethasone.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr.Naser Ghiasnejad Omrani
Street address
Sina Hospital, Imam khomeinyAve, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Naser Ghiasnejad Omran
Street address
Emam Khomeini St. Hasanabad Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Tehran University of Medical Science
Full name of responsible person
Dr.Naser Ghiasnejad Omran
Position
Resident
Other areas of specialty/work
Street address
Sina Hospital, Imam Khomeini Ave, Tehran
City
Tehran
Postal code
Phone
+98 216312000
Fax
Email
Naseromran@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Naser Ghiasnejad Omran
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, Imam Khomeini Ave, Tehran
City
Tehran
Postal code
Phone
+98 216312000
Fax
Email
Naseromran@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.Farsad Imani
Position
Anesthetist, Medical Doctor
Other areas of specialty/work
Street address
Sina Hospital, Imam Khomeini Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
imanifar@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)