Comparison the effect of composition of fentanyl or interathecal suffentanil with 0.5 hyperbaric bupivacaine in spinal anesthesia in elective cesarean patients
Evaluation the effect of fentanyl or sufentanil composition with 0.5 hyperbaric bupivacaine in spinal anesthesia
Design
Clinical trials with control group; community based and pragmatic; with parallel groups; one-way blinded; randomized
Settings and conduct
In this study, 90 patients with elective cesarean section referred to Ali ibn Abitaleb Hospital in Zahedan and eligible for inclusion in the study are selected. Participants are randomly divided into three groups. The first intervention group (fentanyl) will receive 20 μg fentanyl plus 0.5% hyperbaric bupivacaine and the second group (sufentanil) will receive 5.2 μg sufentanil plus 0.5% hyperbaric bupivacaine and the control group (placebo) will receive 0.5 cc distilled water with no additional opioids. The analgesic effects will be evaluated and compared based on 4 grades.
Participants/Inclusion and exclusion criteria
Primigravida; ASA class one and two; Caesarean section due to cephalopelvic disproportion
Intervention groups
The first intervention group (Fentanyl) receiving 20 μg fentanyl plus 0.5% hyperbaric bupivacaine; the second intervention group (sufentanil) receiving 5.2 μg sufentanil plus 0.5% hyperbaric bupivacaine; the control group (placebo) receiving 0.5 cc distilled water with no additional opioids
Main outcome variables
Quality of analgesia; duration of effective analgesia; duration of patient discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171109037340N1
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5799
Email address
dr.arefpour@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2018-05-10, 1397/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of composition of fentanyl or interathecal suffentanil with 0.5 hyperbaric bupivacaine in spinal anesthesia in elective cesarean patients
Public title
Evaluation of the effect of fentanyl or sulfentanil on spinal anesthesia in cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnancy
Primigravida
ASA class 1 and 2
Cesarean section due to cephalopelvic disproportion
Ethics Committee of Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.ZAUMS.REC.1395. 52
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Analgesia quality
Timepoint
Immediately after drug injection
Method of measurement
Based on 4 grades; Excellent: During the procedure, patients feel comfortable with no complainment. Good: brief discomfort with no need of additional medication. Moderate: Unpleasant but controllable with additional medication such as phenthanyl, propofol, dormicom and the like. Poor: Inability to control even with an additional drug
2
Description
The duration of effective analgesia
Timepoint
The interval between the initiation of drug administration in each group until the first request of analgesia by patients
Method of measurement
1-awake and anxious; 2- awake and calm; 3- sleepy but easily awake; 4- sleepy but not easily awake.
3
Description
Duration of discharge
Timepoint
The interval between the initiation of drug administration in each group until the time of discharge from hospital
Method of measurement
Day
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: receiving 20 μg fentanyl plus 0.5% hyperbaric bupivacaine
Category
Treatment - Drugs
2
Description
Second intervention group: receveing 5.2 μg sufentanil plus 0.5% hyperbaric bupivacaine
Category
Treatment - Drugs
3
Description
Control group: receiving 0.5 cc distilled water without any additional opioid
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abi talib Zahedan Hospital
Full name of responsible person
Dr Shahram Borjian Boroujeni
Street address
Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
Dr.borjian@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
dr.taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Arefpour
Position
Anesthesiology Residence
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Zahedan Ali-ebn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
Dr.arefpour@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Shahram Borjian Boroujeni
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Operation room, Ali-ebn Abi Taleb Hospital, Hesabi Sq., Daneshgah Ave., Zahedan, Sistan and Balouchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5730
Email
Dr.borjian@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Arefpour
Position
Anesthesia Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Operation room, Ali-ebn Abi Taleb Hospital, Hesabi Sq., Daneshgah Ave., Zahedan, Sistan and Balouchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5731
Email
Dr.arefpour@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available