Treatment of postoperative nausea and vomiting after spinal anestheisa for cesarean delivery: a randomized comparison of midazoalm, ondansetron, and a combination
The aim of the present study was to compare efficacy of using intravenous midazoalm, ondansetron, and midazolam in combination with ondansetron for treatment of nausea and vomiting after cesarean delivery in parturient underwent spinal anesthesia. One-hundred thirty two parturient were randomly allocated to one of three group: Group M (n = 44) that received intravenous midazoalm 30 µg/kg; Group O (n = 44) which received intravenous ondansetron 8 mg and Group MO (n = 44) that received intravenous midazoalm 30 µg/kg combined with intravenous ondansetron 8 mg if patients had vomiting or VAS of nausea ≥ 3 during surgery (after umbilical cord clamping) and 24 hours after that. The incidence and severity of vomiting episodes and nausea with visual analogue scale (VAS) > 3 was evaluated at 2hr, 6hr, and 24 hr after injection of study drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201308877N1
Registration date:2012-02-05, 1390/11/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-05, 1390/11/16
Registrant information
Name
Mohsen Chitsazi
Name of organization / entity
Isfahan University of Medical Sences
Country
Iran (Islamic Republic of)
Phone
+98 31 1227 6978
Email address
mch61084@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-12-01, 1389/09/10
Expected recruitment end date
2012-03-29, 1391/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment of postoperative nausea and vomiting after spinal anestheisa for cesarean delivery: a randomized comparison of midazoalm, ondansetron, and a combination
Public title
Postoperative nausea and vomiting after cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA I; age between 18 to 45 years old; scheduled for elective cesarean delivery under spinal anesthesia and signing written informed consent to participate in the present study. Exclusion criteria: patients who had smoking habit; obstetric complications or any evidence of fetal compromise; patients who had history of motion sickness; previous postoperative emesis; gastrointestinal disease or administration of antiemetic medication in the previous 24 hours; having allergy to the study drugs and any contraindication for spinal anesthesia.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
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
Isfahan University of Medical Siences Ethics Committee
Street address
Isfahan
City
Isfahan
Postal code
8199657343
Approval date
2010-12-22, 1389/10/01
Ethics committee reference number
289268
Health conditions studied
1
Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
Postoperative nausea and vomiting
Timepoint
Half an hour afer Intevention
Method of measurement
Visual analogous scale(VAS)
Secondary outcomes
1
Description
Sedation
Timepoint
Half, 2,4 and 24 hours after intervention.
Method of measurement
Ramsay sedation scale
Intervention groups
1
Description
Group MO (n = 44) that received intravenous midazoalm 30 µg/kg combined with intravenous ondansetron 8 mg
Category
Treatment - Drugs
2
Description
Group O (n = 44) which received intravenous ondansetron 8 mg;
Category
Treatment - Drugs
3
Description
Group M (n = 44) received intravenous midazoalm 30 µg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mitra jabalameli md. anesthiologist
Street address
Ostad Motahari St., Felezi Bridge, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mr. Moradi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
289268
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Associate professor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
8199657343
Phone
+98 31 1236 7001
Fax
+98 31 1233 5030
Email
mitrajabalameli@mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mitra Jabalameli
Position
Associate professor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
8199657343
Phone
+98 31 1227 6978
Fax
+98 31 1233 5030
Email
mitrajabalamli@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Chitsazi
Position
MD, Resident of anesthiology
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
8199657343
Phone
+98 31 1227 6978
Fax
+98 31 1233 5030
Email
mch61084@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)