Effect of oral dextromethorphan on postoperative nausea and vomiting after nose mucosal surgery in admitted patients in Valiasr hospital in Zanjan in 1394.
The purpose of the study was to determine the effect of oral dextromethorphan on post-operative nausea and vomiting suffered by patients undergoing nasal-mucosal surgery. The research plan was to do a randomized, mono-central, double blind clinical trial on two groups of patients, control and placebo. The inclusion and exclusion criteria were, respectively: 15-50 years of age, and personal discontent or having allergic reactions to the drug. 56 patients participated in the trial. The control group received 90 mg dextromethorphan 3 hours before anesthesia; 12 hours after the surgery, nausea and vomiting were evaluated using the Rhode index. Primary outcome measures included nausea and vomiting and the frequency of these phenomena.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081723661N1
Registration date:2015-10-27, 1394/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Fateme Karimi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 0651
Email address
jalili@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan university of Medical Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral dextromethorphan on postoperative nausea and vomiting after nose mucosal surgery in admitted patients in Valiasr hospital in Zanjan in 1394.
Public title
Dextromethorphan effect on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Admitted patients undergoing elective nasal mucosal surgery;Any Riskfactors for Anesthesia (ASA I ,II ); Ages between 15-50.
Exclusion criteria:Personal discontent; Medications that reduce or stimulate post operative nausea and vomiting; History of GI surgery; Pregnants; Fasting time less than 8 hours; long and difficult intubation; Drug allergy.
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, beginning of Jomhuri Blvd, Azadi square, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
zums.rec.1394.19
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
nausea and vomiting
Timepoint
12 & 24 hrs after surgery
Method of measurement
Rhode index
Secondary outcomes
1
Description
vertigo
Timepoint
12 & 24 hrs after surgery
Method of measurement
questionnaire
2
Description
respiratory distress
Timepoint
12 & 24 hrs after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
dextromethorphan syrp 90 mg/kg 3 hours before surgery in case group.
Category
Prevention
2
Description
90mg/kg oral sugar solution as placebo 3 hours before surgery in control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Fateme Karimi
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University Of Medical Science
Full name of responsible person
Dr Saeid Jalili
Street address
Zanjan University of Medical Sciences, beginning of Jomhuri Blvd, Azadi square, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University Of Medical Science
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
Zanjan University of Medical Sciences
Full name of responsible person
Fateme Karimi
Position
MD/ student
Other areas of specialty/work
Street address
No5, Orcid apartment, 2nd alley, Arazi sabt
City
Zanjan
Postal code
Phone
+98 24 3347 0919
Fax
Email
dr.fateme.karimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Saeid Jalilli
Position
General Anesthesiologist
Other areas of specialty/work
Street address
Mousavi hospital, Gavazang road, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3313 0000
Fax
Email
jalili@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fateme Karimi
Position
MD/ student
Other areas of specialty/work
Street address
No5, Orcid apartment, 2nd alley, Arazi sabt
City
Zanjan
Postal code
Phone
+98 24 3347 0919
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)