Evaluation of the prophylactic infusion effect of phenylephrine on hypotension in cesarean section under spinal anesthesia
Design
In this double-blind clinical trial study, pregnant women candidates for cesarean section under spinal anesthesia were included. The patients were randomly allocated into intervention or control groups based on generated computer numbers.
Settings and conduct
This study was conducted on pregnant women undergoing cesarean section under spinal anesthesia admitted to Urmia Shahid Motahari. this study was a double-blind study and both of the patients and the researcher were blind to the belonging of the patients to the intervention or control group.
Participants/Inclusion and exclusion criteria
In this double-blind clinical trial study, pregnant women candidates for cesarean section under spinal anesthesia and ASA I and ASA II were included.
Patients with classic hypertension or gestational hypertension, patients with pulmonary, cardiovascular, and cerebrovascular diseases, and also fetal abnormalities were excluded.
Intervention groups
The participants were randomly divided into two groups based on generated computer numbers. Patients in the intervention group received 100 micrograms per hour of Phenylephrine infusion. Patients in the control group received the same amount of normal saline.
Main outcome variables
Hypotension which was considered as a decrease in systolic blood pressure by 80% of the baseline;
Hypertension was considered as an increase in systolic blood pressure above 120% of the baseline.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049639N1
Registration date:2020-12-20, 1399/09/30
Registration timing:retrospective
Last update:2020-12-20, 1399/09/30
Update count:0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Hadi Houshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyar.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2020-03-19, 1398/12/29
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Evaluation of the prophylactic infusion effect of Phenylephrine on hypotension in cesarean section under spinal anesthesia
Public title
Evaluation of the Phenylephrine effect on hypotension in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women candidates for cesarean section under spinal anesthesia
American Society of Anesthesiologists classification system I and II (ASA II and ASA II)
Exclusion criteria:
Patients with classical hypertension
Gestational hypertension
Patients with pulmonary and cardiovascular diseases
Patients with cerebrovascular disease
Fetal abnormality
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using random allocation computer software. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients allocated into two groups according computer generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blind clinical trial. participants and researcher were unaware about the patient belonged to the intervention or control groups. The drug were injected by an anesthesia technician (other than the researcher) who was unaware of the content of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.UMSU.REC.1397.408
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
Hypotension, which was considered as a decrease in systolic blood pressure by 80% of the baseline.
Timepoint
Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention.
Method of measurement
Blood pressure monitoring device
Secondary outcomes
1
Description
Hypertension was considered as an increase in systolic blood pressure above 120% of the baseline
Timepoint
Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention.
Method of measurement
Blood pressure monitoring device
2
Description
Nausea
Timepoint
Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention.
Method of measurement
Interview
3
Description
Vomiting
Timepoint
Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention.
Method of measurement
Interview
4
Description
Bradycardia (decrease in heart rate to less than 60 beats per minute)
Timepoint
Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention.
Method of measurement
Heart rate monitoring device.
Intervention groups
1
Description
Intervention group: patients in the intervention group received 100 micrograms per hour of Phenylephrine infusion
Category
Treatment - Drugs
2
Description
Control group: patients in the control group received 100 micrograms of normal saline