Background & Objective: pain is one of the most common post-op complication. In the case of cesarean the post-op pain can result in some complication for both mother and neonate. Many methods have been proposed for the post-op pain. Intratechal opioid or dexmedetomedine injections are two examples of these methods. In this study the efficacy of intratechal dexmedetomedine and sufentanil for post-op pain has been compared with each other. Design: Double blind clinical trial. Setting: patients were divided into two groups randomly: bupivacaine - dexmedetomedine and bupivacaine -sufentanil All patients was given Serum ringer 500cc and metocloperamide 10mg before spinal anesthesia Inclusion criteria: sixty ASA I, II full term pregnant women between 18 and 35 years who require for elective Cesarean Section. Exclusion criteria: patients with HTN, DM and other systemic disease. Intervention: Patients were randomly allocated to receive intrathecally either 10 mg hyperbaric bupivacaine plus 0.05 ml (5 μg) dexmedetomidine (group MD) or 10 mg hyperbaric bupivacaine plus 0.5 ml (2.5 μg) sufentanil (group MS). Main outcomes: BP, HR, nausea and vomiting, pain score
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307236625N2
Registration date:2013-09-08, 1392/06/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Mozaffar Rabiee
Name of organization / entity
Babaol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
m_rabiee@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-08-13, 1392/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of analgesic effect of intrathecal sufentanil-bupivacaine versus dexmedetomedine -bupivacaine in cesarean delivery
Public title
Duration of analgesia effect of intrathecal sufentanil-bupivacaine versus dexmedetomedine -bupivacaine in cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: sixty ASA I, II; full term pregnant; women between 18 and 35 years who require for elective Cesarean Section.
Exclusion criteria: patients with HTN; DM and other systemic disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-02-05, 1391/11/17
Ethics committee reference number
2006/30/ژ/پ
Health conditions studied
1
Description of health condition studied
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 analgesia
Timepoint
1, 3, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogues Scale
Secondary outcomes
1
Description
blood Pressure
Timepoint
0,3,5,10,30,60 min and 3,6,12,24 hour after surgery
Method of measurement
BP Cuff
2
Description
Heart Rate
Timepoint
0,3,5,10,30,60 min and 3,6,12,24 hour after surgery
Method of measurement
ECG
3
Description
Nausea & Vomiting
Timepoint
The start of spinal until 24 hours after surgery
Method of measurement
Observation
Intervention groups
1
Description
Bupivacaine-Dexmedetomidine groups:10 mg hyperbaric bupivacaine plus 0.05 ml (5 μg) dexmedetomidine
Category
Treatment - Drugs
2
Description
Bupivacaine-Sufentanil groups: 10 mg hyperbaric bupivacaine plus 0.5 ml (2.5 μg) sufentanil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Seyed Mozaffar Rabiee
Street address
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 Seyed Mozaffar Rabiee
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
drm_rabiee@yahoo.com؛ ans_dep@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 Seyed Mozaffar Rabiee
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
drm_rabiee@yahoo.com؛ ans_dep@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 Seyed Mozaffar Rabiee
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
drm_rabiee@yahoo.com؛ ans_dep@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)