Comparison of preload and coload of ringer lactate to prevent hypotension during elective cesarean section under spinal anesthesia
Design
Phase-III single-blind randomized clinical trial on 60 patients, randomization with sealed envelopes
Settings and conduct
This single-blind randomized clinical trial will include 60 women aged 18-45 years with singleton term pregnancies referred to Khalij Fars Hospital, Bandar Abbas for elective cesarean section under spinal anesthesia. Patients will randomly be allocated to two equal groups: the preload group will receive 10 ml/kg Ringer’s solution within 15 min before the blockade, while the co-load group will receive this amount of Ringer’s during the blockade. Hemodynamic parameters at different time points, maternal complications, and neonatal outcomes will be recorded and compared between groups. The investigator and the outcome assessors will be blinded to the grouping of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-45 years
Singleton term pregnancy
Elective cesarean section
Spinal anesthesia
American Society of Anesthesiologists (ASA) class I or II
Exclusion criteria:
Twin or multiple pregnancy
ASA class above II
Hypertension or cardiovascular diseases
Contraindications of spinal anesthesia
Hypersensitivity to bupivacaine
Renal disorders
Severe hemorrhage during surgery requiring blood transfusion
Uterine atony requiring hysterectomy
Block failure or incomplete block demanding extra anesthetics
Intervention groups
The preload group will receive 10 ml/kg Ringer’s solution within 15 min before the blockade, while the co-load group will receive this amount of Ringer’s during the blockade.
Main outcome variables
Hypotension during cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110313006044N5
Registration date:2022-03-25, 1401/01/05
Registration timing:registered_while_recruiting
Last update:2022-03-25, 1401/01/05
Update count:0
Registration date
2022-03-25, 1401/01/05
Registrant information
Name
Hashem Jarineshin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
hjarineshin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preload and coload of ringer lactate to prevent hypotension during elective cesarean section under spinal anesthesia
Public title
Preload versus coload of ringer lactate to prevent hypotension during elective cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-45 years
Singleton term pregnancy
Elective cesarean section
Spinal anesthesia
American Society of Anesthesiologists (ASA) class I or II
Exclusion criteria:
Twin or multiple pregnancy
ASA class above II
Hypertension or cardiovascular diseases
Contraindications of spinal anesthesia
Hypersensitivity to bupivacaine
Renal disorders
Severe hemorrhage during surgery requiring blood transfusion
Uterine atony requiring hysterectomy
Block failure or incomplete block demanding extra anesthetics
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with individuals as units of randomization along with allocation concealment: 60 unclear envelopes and 60 cards with the names of the groups (A, B) will be prepared (30 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A or B based on the card inside the selected envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the difference in the interventions the participants cannot be blinded. However, the investigator and the outcome assessor will be unaware of patients' interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Jomhouri Eslami Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
HUMS.REC.1397.170
Health conditions studied
1
Description of health condition studied
Hypotension during cesarean section
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
Maternal blood pressure
Timepoint
Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit
Method of measurement
Monitoring device
Secondary outcomes
1
Description
Maternal mean arterial pressure
Timepoint
Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit
Method of measurement
Monitoring device
2
Description
Maternal heart rate
Timepoint
Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit
Method of measurement
Monitoring device
3
Description
Maternal oxygen saturation
Timepoint
Baseline, immediately after spinal anesthesia, then at 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 60 min after spinal anesthesia and in the recovery unit
Method of measurement
Monitoring device
4
Description
Neonatal Apgar score
Timepoint
1 and 5 min after delivery
Method of measurement
Clinical assessment
Intervention groups
1
Description
Intervention group: Patients in the preload group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) within 15 min before the blockade
Category
Prevention
2
Description
Intervention group: Patients in the co-load group will receive 10 ml/kg Ringer’s solution (Samen Pharmaceutical Co., Mashhad, Iran) during the blockade
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalij Fars Hospital, Bandar Abbas
Full name of responsible person
Hashem Jarineshin
Street address
Pardis Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919783141
Phone
+98 76 3367 0280
Email
hjarineshin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Imam Hossein Blvd., across from Kargaran Sports Complex
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
979199155
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
979199155
Phone
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD