Comparison of midazoalm, ondansetron, and a combination for treatment of postoperative nausea and vomiting after spinal anestheisa for cesarean delivery
The aim of this double-blinded randomized clinical trial is comparing the 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 parturients are randomly allocated to one of three group: Group M (n = 44) intravenous midazoalm 30 µg/kg; Group O (n = 44) intravenous ondansetron 8 mg; Group MO (n = 44) intravenous midazoalm 30 µg/kg combined with intravenous ondansetron 8 mg.These drugs is administered after umbilical cord clamping if patients have vomiting or VAS of nausea ≥ 3 until 24 hours postoperatively. All parturients receive 10 ml/kg ringer lactate solution. Then spinal anaesthesia is done in sitting position using 25 G sprotte needle. Participants are including parturients with ASA physical status I-II, scheduled for elective cesarean section, under spinal anaesthesia and exclude with suspicious to bleeding disturbances, atopia, diabetes mellitus, presence of liver or kidney diseases, drugs abuse, complicated pregnancy and preeclampsia. The incidence of nausea and vomiting and nausea scale is evaluated among the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201302405N10
Registration date:2012-02-16, 1390/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Mitra Jabalameli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7472
Email address
jabalameli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-10-12, 1389/07/20
Expected recruitment end date
2012-01-27, 1390/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of midazoalm, ondansetron, and a combination for treatment of postoperative nausea and vomiting after spinal anestheisa for cesarean delivery
Public title
Comparison of midazoalm, ondansetron, and a combination for treatment of postoperative nausea and vomiting after spinal anestheisa for cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients; ASA physical status I-II; scheduled for elective cesarean section; using spinal anesthesia; Exclusion Criteria: suspicious to bleeding disturbances; atopia; diabetes mellitus; presence of liver or kidney diseases; drugs abuse; complicated pregnancy; preeclampsia
Age
From 16 years old to 45 years old
Gender
Female
Phase
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
Vice-chancellor for Research, Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research, Gostaresh Building, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
22265
Health conditions studied
1
Description of health condition studied
Complications of anaesthesia during pregnancy
ICD-10 code
O29.8
ICD-10 code description
Other complications of anaesthesia during pregnancy
Primary outcomes
1
Description
Frequency of nausea and vomiting
Timepoint
at recovery, 4, 8, 12 and 24 hours after surgery
Method of measurement
counting
2
Description
nausea intensity
Timepoint
at recovery, 4, 8, 12 and 24 hours after surgery
Method of measurement
Visual Analogous Scale (VAS) and scoring from 0 to 10
Secondary outcomes
1
Description
opioid consumption
Timepoint
at recovery, 4, 8, 12 and 24 hours after surgery.
Method of measurement
in milligramme of opioid
Intervention groups
1
Description
intravenous midazoalm 30 µg/kg. Duration of intervention: single dose in 10 seconds if patients have vomiting or VAS of nausea ≥ 3. Duration of treatment: on demand after umbilical cord clamping, During spinal anaesthesia until 24 hours postoperatively
Category
Treatment - Drugs
2
Description
intravenous ondansetron 8 mg. Duration of intervention: single dose in 10 seconds if patients have vomiting or VAS of nausea ≥ 3. Duration of treatment: on demand after umbilical cord clamping, During spinal anaesthesia until 24 hours postoperatively
Category
Treatment - Drugs
3
Description
intravenous midazoalm 30 µg/kg combined with intravenous ondansetron 8 mg. Duration of intervention: single dose in 10 seconds if patients have vomiting or VAS of nausea ≥ 3. Duration of treatment: on demand after umbilical cord clamping, During spinal anaesthesia until 24 hours postoperatively
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Medical Center
Full name of responsible person
Dr. Mitra Jabalameli
Street address
Pol fellezi
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Payman Adibi
Street address
Vice-chancellor for Research, Gostaresh Building, Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
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, 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
Specialist and Associate professor of Anaesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anaesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anaesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anaesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.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
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anaesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anaesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
00
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)