A Comparison the effects of lidocaine - Dexamethasone with Lidocaine -epinephrine intrathecal on quality of sensory block in electhve cesarean sectionin .
the aim of this double blinded randomized clinical trial was evaluation the efficacy of lidocaine- epinephrine or lidocaine -dexamethasone intrathecal on quality of sensory block in elective cesarean section.a total 90 ASA physical status I-II women undergoing elective cesarean section with spinal anesthesia were randomized to 3 groups.group 1:epinephrine ,group2:dexamethasone and group3:saline.The spinal anesthesia was done in sitting position using 25 gauge needle .epinephrine group recived 75mg lidocaine and 100microg ram epinephrine,
dexamethasone group recived 75mg lidocaine and 4mg dexamethasone and saline group recived 75mg lidocaine and 1ml normal saline.sensory onset time and duration of senory block compard among the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205279874N1
Registration date:2012-08-14, 1391/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Freshteh Naziri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
freshteh.naziri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison the effects of lidocaine - Dexamethasone with Lidocaine -epinephrine intrathecal on quality of sensory block in electhve cesarean sectionin .
Public title
A Comparison the effects of lidocaine - dexamethasone with Lidocaine -epinephrine intrathecal on quality of sensory block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: elective cesarean section in pregnant women 18-35 years ,ASA ClassI, II ,elective cesarean section
Exclusion criteria from the study: patients with a history of alergy, psychiatric disorder, chronic pain, those taking corticosteroids , alcohol and drug dependence , emergency cesarean
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Babol University Of Medical Sciences
Street address
Daneshgah Square - Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2012-04-30, 1391/02/11
Ethics committee reference number
6262/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Other complications of Anesthesia during pregnancy
ICD-10 code
029.8
ICD-10 code description
Other complications of anaesthesia during pregnancy
Primary outcomes
1
Description
The duration of sensory block
Timepoint
Every 15 minutes until 4 dermatom regretion
Method of measurement
Pin prik test with needle
2
Description
Onset of sensory block
Timepoint
Time from intrathecal injection to highst sensory level
Method of measurement
Pin prik test with needle
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 3 min to end of surgery
Method of measurement
Manometer
2
Description
Hear rate
Timepoint
Every 5 min to recovery
Method of measurement
ECG
3
Description
Nausea
Timepoint
During delivery to24 hours
Method of measurement
Questioning from patient(having or not)
4
Description
Vomiting
Timepoint
During delivery to 24 hours
Method of measurement
Questiening from patient
5
Description
Pain
Timepoint
Recovery room to 24 hours
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intrathecal injection of 75 mg lidocaine and 1 cc normal saline.
Category
Treatment - Drugs
2
Description
Intrathecal injection of 75mg lidocaine and 100 microgram epinephrine
Category
Treatment - Drugs
3
Description
Intrathecal injection of 75 lidocaine and 4mg dexamethasone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Freshteh Naziri
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol 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
Babol University Of Medical Sciences
Full name of responsible person
Dr Freshteh Naziri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
freshteh.naziri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Freshteh Naziri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
freshteh.naziri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Freshteh Naziri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
freshteh.naziri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)