The effect of dextrose injection in preventing postoperative nausea and vomiting in patients undergoing cholecystectomylaparoscopic surgery
Design
The study will be double blind and clinical trial.100 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients candidate for cholecystectomylaparoscopic surgery in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All candidates for laparoscopic cholecystectomy; age between 30 and 70 years; AqSA class I and II; patients under general anesthesia; the duration of surgery is between 60-150 minutes; absence of Parkinson's disease, motion sickness or history of chemotherapy; absence of diabetes
Exclusion criteria:All patients who do not undergo general anesthesia for any reason; patients who suffer cardiac arrest during surgery; patients whose surgery lasts more than 180 minutes; patients who are referred to the intensive care unit for any reason
Intervention groups
Intervention group: will receive 10 millileter in kilogeram in hour of Ringer's lactate serum with 500 miligram in kilogeram of 5% dextrose.
Control group: they will receive Ringer's lactate serum with 0.9% normal saline with the same volume as the intervention group.
The solutions are infused 5 minutes before the induction of anesthesia until the end of the procedure.
Main outcome variables
Vomitting; nausea; Dose of metoclopramide in 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N176
Registration date:2022-10-03, 1401/07/11
Registration timing:prospective
Last update:2022-10-03, 1401/07/11
Update count:0
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dextrose injection in preventing postoperative nausea and vomiting in patients undergoing cholecystectomylaparoscopic surgery
Public title
The effect of dextrose injection in preventing postoperative nausea and vomiting in patients undergoing cholecystectomylaparoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All candidates for laparoscopic cholecystectomy
Age between 30 and 70 years
ASA class I and II
Patients under general anesthesia
The duration of surgery is between 60-150 minutes
Absence of Parkinson's disease, motion sickness or history of chemotherapy
Absence of diabetes
Exclusion criteria:
All patients who do not undergo general anesthesia for any reason.
Patients who suffer cardiac arrest during surgery.
Patients whose surgery lasts more than 180 minutes.
Patients who are referred to the intensive care unit for any reason.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping. The specialist assistant is unaware of the type of operation in each group and the surgeon is aware of the type of operation and patients are not aware of their group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
IR.ARAKMU.REC.1401.048
Health conditions studied
1
Description of health condition studied
Cholecystectomy laparoscopic surgery
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy
Primary outcomes
1
Description
Vomitting
Timepoint
In recovery, 2, 4, 6, 12 and 24 hours after the operation
Method of measurement
Score from 0 to 4 (no vomiting gets zero and frequent vomiting gets 4.)
2
Description
Severe nausea
Timepoint
Recovery, 2, 4, 6, 12 and 24 hours after the operation
Method of measurement
VAS visual analog scale
3
Description
Mean of dose of metoclopramide in 24 hours
Timepoint
At the end of the study
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 millileter in kilogeram in hour of Ringer's lactate serum along with 500 miligram in kilogeram of 5% dextrose will be given. The solutions are infused 5 minutes before induction of anesthesia until the end of the procedure.
Category
Treatment - Drugs
2
Description
Control group: they will receive Ringer's lactate serum with 0.9% normal saline with the same volume as the intervention group. The solutions are infused 5 minutes before the induction of anesthesia until the end of the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad shafie
Position
medicine student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Complex Payambar azam, Basij squre, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
mohamadshafie30@yahoo.com
Web page address
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