Comparison effect of addition of Dexmedetomidine and Fentanyl to Lidocaine 5% in spinal anesthesia to increase postoperative analgesia in women candidate elective cesarean
Aim of this study is comparison effect of addition of Dexmedetomidine and Fentanyl to Lidocaine 5% in spinal anesthesia to increase postoperative analgesia in women candidate elective cesarean.This study is clinical trial and double blind.84 patient candidate elective cesarean in Taleghani hospital in Arak arrive this study. Inclusion criteria: 18 to 35 years; single pregnancy; candidate cesarean with spinal anesthesia; elective cesarean .Exclusion criteria: multiple pregnancy; allergy for Fentanyl and dexmedetomidine; infection in site of spinal anesthesia. We will divide patients in two groups randomly. We will inject 25 micro gram Fentanyl into Lidocaine 5% in first group and we will inject 30-35 micro gram (0/5 micro gram in kilogram) Dexmedetomidine into Lidocaine 5% in second group. We will record oxygen saturation, heart rate and blood pressure and breathing every 15 minute to end of surgery. We will record pain in recovery, 4 and 12 and 24 hours after cesarean by Visual Analog Scale. We will record duration of analgesia after cesarean by requesting the first analgesic drug after surgery and mean of analgesic drug use in 24 hours after cesarean.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012320258N28
Registration date:2017-01-31, 1395/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor research,Arak University of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of addition of Dexmedetomidine and Fentanyl to Lidocaine 5% in spinal anesthesia to increase postoperative analgesia in women candidate elective cesarean
Public title
Comparison effect of addition of Dexmedetomidine and Fentanyl to Lidocaine 5% in spinal anesthesia in women candidate elective cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 35 years; single pregnancy; candidate cesarean with spinal anesthesia; elective cesarean.
Exclusion criteria: multiple pregnancy; allergy for Fentanyl and dexmedetomidine; infection in site of spinal anesthesia; lack of consent.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.ARAKMU.MU.REC.1395.138
Health conditions studied
1
Description of health condition studied
Elective cesarean
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minute to recovery
Method of measurement
millimeter Hg
2
Description
Heart rate
Timepoint
every 5 minute to recovery
Method of measurement
Beat in minute
3
Description
Oxygen saturation
Timepoint
every 15 minute to recovery
Method of measurement
Percent
4
Description
Breathing
Timepoint
Every 15 minute to recovery
Method of measurement
Number in minute
5
Description
Pain
Timepoint
In recovery and 4 and 12 and 24 hours after cesarean
Method of measurement
Visual Analogue Scale
6
Description
Duration of analgesia
Timepoint
requesting the first analgesic drug
Method of measurement
Miligeram
7
Description
Narcotic drug
Timepoint
24 hours after cesarean
Method of measurement
Miligeram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : We will inject 25 micro gram Fentanyl into Lidocaine 5%.
Category
Treatment - Drugs
2
Description
Intervention group: we will inject 30-35 micro gram (0/5 micro gram in kilogram) Dexmedetomidine into Lidocaine 5%.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Taleghani Hospital, Emam Khomeini Street
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Arak University of Medical Sciences