Protocol summary

Summary
Considering glucose infusion effects during surgery, in current double-blinded randomized clinical trial, we aimed to evaluate effect of glucose addition to ringer solution on maternal hemodynamic status subsequent to epidural analgesia cesarean section. Ninety women aged between 18 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia will be enrolled and women suffering systemic diseases, mental disorders and body mass index more than 30 kilograms per meter square will be excluded. Prior to surgery, equally, patients will be divided to control and study groups, by randomization. Study group (45 cases) will receive 1% glucose solution in ringer serum, and control group (45 cases) will receive distilled water added to ringer serum. During administration of epidural analgesia, 8 ml/kg body weight bullous intravenous fluid will be infused during 15 minutes and subsequently, infusion will be continued till end of the operation in dose of 15-20 ml/kg/ min. Study group solution (1% glucose) will be prepared by adding 10 gram of glucose (20 ml) to 1-liter ringer serum and control group solution will be prepared by adding same amount of distilled water to ringer serum, as well. Study parameters including basal hemodynamic variables (blood pressure, heart rate) and prevalence of hypotension side effects including nausea, vomiting and respiratory suppression will be recorded. Overall vasopressors dosage and preoperative and postoperative maternal blood glucose level will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201702077013N17
Registration date: 2017-02-18, 1395/11/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-18, 1395/11/30
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-02-11, 1395/11/23
Expected recruitment end date
2017-08-14, 1396/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of glucose containing crystalloid infusion on maternal hemodynamic status during spinal anesthesia for cesarean section
Public title
Glucose containing crystalloid effect on hemodynamic status during cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: class I in American society of anesthesiology; aged between 18-40 years old; term pregnancy; singleton pregnancy; candidate for elective cesarean section; candidate for epidural analgesia. Exclusion criteria: emergent cesarean section; systemic diseases (renal, cardiac, pulmonary, hepatic, neuromuscular and etc.); mental disorders; body mass index more than 30 kilograms per meter square; history of glucose intolerance; consumption of drugs effecting glucose metabolism; allergy to bupivacaine; contraindications for epidural analgesia; fetal complication (asphyxia, meconium stained amniotic fluid).
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2017-01-15, 1395/10/26
Ethics committee reference number
IR.TBZMED.REC.1395.1110

Health conditions studied

1

Description of health condition studied
Hemodynamic changes during cesarean section by epidural analgesia
ICD-10 code
O74.9
ICD-10 code description
Complication of anaesthesia during labour and delivery, unspecified

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
each 2 minutes till fetal birth, then each 5 minutes till end of the operation
Method of measurement
measuring patients blood pressure

2

Description
Dyastolic blood pressure
Timepoint
each 2 minutes till fetal birth, then each 5 minutes till end of the operation
Method of measurement
measuring patients blood pressure

3

Description
Mean arterial pressure
Timepoint
each 2 minutes till fetal birth, then each 5 minutes till end of the operation
Method of measurement
calculating using mean arterial pressure formula

4

Description
Heart rate
Timepoint
each 2 minutes till fetal birth, then each 5 minutes till end of the operation
Method of measurement
Using pulseoxymetery

Secondary outcomes

1

Description
maternal blood glucose
Timepoint
before operation, after operation
Method of measurement
using blood sugar glucometer

2

Description
measurement the dosage of vasopressor agents used
Timepoint
after operation
Method of measurement
measuring dosage of vasopressor agents used

Intervention groups

1

Description
Control group: Placebo group solution will be prepared by adding 20 ml distilled water to 1-liter ringer serum. During administration of epidural analgesia, 8 ml/kg body weight bullous intravenous fluid will be infused during 15 minutes and subsequently, infusion will be continued till end of the operation in dose of 15-20 ml/kg/ min
Category
Treatment - Other

2

Description
Study group: Study group solution will be prepared by adding 20 ml glucose (10 gram) glucose to 1-liter ringer serum. During administration of epidural analgesia, 8 ml/kg body weight bullous intravenous fluid will be infused during 15 minutes and subsequently, infusion will be continued till end of the operation in dose of 15-20 ml/kg/ min
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Women's Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Baghshomal crossroad, North artesh street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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