Protocol summary

Study aim
Comparison effect of oral or intravenous glucose pretreatment for improvement of recovery stay compared with control group
Design
In this double-blind randomized controlled clinical trial, faze 3 study with parallel groups, 90 patients undergoing laparotomy were randomly divided into 3 groups of 30 divided into the first group of intravenous glucose, the oral glucose guided group and the third group (control group) oral normal saline, 6 hours after fasting preoperatively were prescribed and recovery conditions were compared in three groups.
Settings and conduct
This study was carried out on patients undergoing laparotomy in Alzahra hospital in Isfahan in 1399. This study is done in two sucrose methods. Patients are unaware of the type of solution they are given and no explanation is given about the type of solution being given or injected. The solution is also prescribed by the patient's presenter, but the information is collected by an operating room staff who is not in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:: Patients are candidates for laparotomy surgery, age range 18 to 65 years, physical health status 1 and 2. Non-entry criteria: Patients with diabetes and reflex, patients who need to take anti emetic drugs before surgery.
Intervention groups
In this study 90 patients undergoing laparotomy were divided into 3 groups of 30 each. All three groups received 10 ml/kg of serum 1/3-2/3 at the time of preoperative fasting, and 6 hours later, the first group received 1 g / kg glucose in 50 ml of normal saline intravenously injections, the second group 1 g / kg glucose in 50 Ml of saline orally and the third group receive 50 ml of normal saline orally.
Main outcome variables
Postoperative pain, length of stay in recovery, nausea, vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N55
Registration date: 2021-07-10, 1400/04/19
Registration timing: retrospective

Last update: 2021-07-10, 1400/04/19
Update count: 0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of two approach for Improvement of patients Conditions in Recovery Using of oral or interavenous Glucose Pretreatment in Laparotomy surgeries
Public title
Comparison effect of oral glucose administration and preoperative injection on patient status in recovery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient undergoing laparotomy Patient's consent to participate in the study American Society of Anesthesiologists(ASA) : 1 or 2
Exclusion criteria:
Body Mass Index 30 or above diabetes reflux Requires preoperative Antiemetic medication
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients is done using Random Allocation Aoft ware(RAS). The total sample size (90 people) is entered into the software and then the number of study groups (3 groups) is determined. The software output contains a list that distributes numbers 1 to 90 randomly in three columns. Patients are divided into groups according to the time list of admission to the hospital to reach the required sample size in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind study. Patients are unaware of the type of solution they receive. The solution used by the researcher is also prescribed for patients, but the information is collected by one of the operating room personnel who is unaware of the type of solution being received.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2019-02-09, 1397/11/20
Ethics committee reference number
IR.MUI.MED.REC.1398.010

Health conditions studied

1

Description of health condition studied
Recovery condition
ICD-10 code
K91.86
ICD-10 code description
cholecystectomy

Primary outcomes

1

Description
post operative pain
Timepoint
during recovery stay
Method of measurement
Visual Analog Scale

2

Description
stay in recovery time
Timepoint
End of recovery
Method of measurement
Calculates the time interval of entry to exit recovery in minutes

3

Description
nausea
Timepoint
During recovery stay
Method of measurement
Ask the patient

4

Description
Vomitting
Timepoint
During recovery stay
Method of measurement
Ask the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 10 ml/ kg of serum 1/3-2/3 at first fasting and after 6 hours, 1 g / kg glucose dissolved in 50 ml of normal saline is injected intravenously.
Category
Prevention

2

Description
Intervention group 2: 10 ml/ kg of serum 1/3-2/3 at first fasting and after 6 hours, 1 g / kg glucose dissolved in 50 ml of normal saline is orally prescribed.
Category
Prevention

3

Description
Control group: 10 ml/ kg of serum 1/3-2/3 at first fasting and after 6 hours, 50 ml of normal saline is orally prescribed.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Ladan Salehfard
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
ladan.salehfard@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Taghi Hashemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
st_hashemi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Jabalameli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Alzahra hospital, Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
Jabalameli@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, school of medicine, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 31 3728081
Email
al.mehrabi@gmail.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
The project is owned by the state agency and cannot be published.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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