History
# Registration date Revision Id
2 2018-07-27, 1397/05/05 73860
1 2017-11-08, 1396/08/17 24668
Changes made to previous revision
This is the first revision

Protocol summary

Summary
Target: Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic cholecystectomy surgery. In a randomized clinical trial, single blind (only patient), non-diabetic candidate patients administered to Rasoul Akram Hospital in 1396 for laparascopic cholecystectomy surgery considered in the study. After informed consent, patients are divided into 3 groups randomly by a non-independent researcher according to the computer number generator. Any group assign to receive a specific diet; Group 1: Infusion of 250 ml dextrose 10%, 2 hours before operation Group 2: 200 ml oral carbohydrate solution (25 gr dextrose), 2 hours before operation Group 3: control group with normal diet and no perception glucose and sugar. Last given meal to all groups is at 8 hours before operation and use of non-carbohydarte oral liquids are prevented 4 hours before surgery. All patients are preperdfor surgery in a same condition. Blood glucose of 3 groups is determined 2 hours before surgery right before study fluid infusion. During all stages of surgery, any patients of any groups will not receive any IV carbohydrate infusion. Anesthetic techniques are equal for every groups. The laparascopic surgery is the choice method for all patients. After surgery Acetaminophen 15 mg/kg, TID is infused for all patients and Plasil ampulla 10 mg altimately TID considered in case of nausea if needed. Any consumption of antiemetic or antianalgesic drugs must be recorded in type, dose and number of using. Blood sugar is evaluated immediately after surgery in recovery room and also in first day after operation at 8:00 AM. It is asked the patient to inform their desire to eat to be recorded. The severity of the pain is achived by Visual Analogue Scale (VAS) in 1, 6 and 24 hours after operation. The score of nausea and vomiting is also checked in 1, 6 and 24 hours after operation by using VAS in the first 24 hours after surgery. Quality Of Recovery questionnire (Includes 5 aspects: Patient support, Comfort, Emotions, Physical independance and Pain) will be given to the patients and according to the taken scores and data of every 3 groups, It wil be analized and compared . The camparison of effect of preoperation carbohydrate therapy on nausea and vomiting and quality of recovery after surgery according to the questionnire and measured indicators will be done.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017090231324N3
Registration date: 2017-11-08, 1396/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 1
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Seyed Hamzeh Mousavie
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 296 7445
Email address
mousavie.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller of Research, IRAN University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea ,vomiting and quality of recovery in laparascopic cholecystectomy surgery
Public title
Investigation the effect of preoperation oral and infusion riched carbohydrate diet on postoperative nausea, vomiting and quality of recovery in laparascopic removal of gallbladder surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Elective laparascopic cholecystectomy for cholelithiasis; Informed consent of patient Exclusion criteria: Acute cholecystitis and Urgent surgery; Patients with open cholecystectomy surgery; Diabetes mellitus; Hepatic and Renal failure; Chronic inflammatory bowel disease; Acute recent infectoion; Patient under corticosteroid therapy or Anabolic and Catabolic drugs; Stomach empeting disorders; Gastroesophageal reflux disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Near Milad tower, Hemmat Highway
City
Tehran
Postal code
Approval date
2017-08-12, 1396/05/21
Ethics committee reference number
IR.IUMS.FMD.REC1395.9021216158

Health conditions studied

1

Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis

Primary outcomes

1

Description
nausea and vomiting score
Timepoint
1, 6 and 24 houre after surgery
Method of measurement
Visual Analogue Scale

2

Description
quality of recovery Score
Timepoint
1, 6 and 24 houre after surgery
Method of measurement
Quality Of Recovery Questionnaire

Secondary outcomes

1

Description
duration of hospitalization
Timepoint
duration of hospitalization after surgery
Method of measurement
patient hospitalization file

2

Description
blood sugar
Timepoint
2 houre before surgery, immediately after surgery and first day after operation at 8:00
Method of measurement
laboratory kit

3

Description
duration of recovery
Timepoint
duration of pateint recovery time
Method of measurement
interview and inspection

4

Description
pain score after surgery
Timepoint
severity of pain at 1, 6 and 24 hour after surgery
Method of measurement
Visual Analogue Scale

5

Description
strat of starving
Timepoint
the time of patient desire to eat
Method of measurement
interview

6

Description
duration of anesthesia
Timepoint
duration of patient anesthesia after surgery
Method of measurement
nursery records and inspection

7

Description
Surgery Complications
Timepoint
Any complication after surgery such as: Bleeding, Ulcer infection, Ileus, Pnomonia ...
Method of measurement
Patient File

8

Description
the amount of analgesic drug administered
Timepoint
after surgery
Method of measurement
patient file

9

Description
the amount of anti nausea drug administered
Timepoint
after surgery
Method of measurement
patent file

10

Description
past medical history(diseae history)
Timepoint
any disease during surgery
Method of measurement
interview

Intervention groups

1

Description
group1: 250 ml dextrose 10% infusion 2 hours before surgery
Category
Treatment - Other

2

Description
group2: 200 ml oral carbohydrate solusion (includes 25 gram of dextrose 10%), 2 horse before surgery
Category
Treatment - Other

3

Description
group 3: control group with normal diet and no perception of glucose and sugar.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Parisa Hosseinpour
Street address
Rasool Akram Hospital, Niayesh street, Satarkhan street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chanceller of research, Iran University of Medical Sciences
Full name of responsible person
vice chanceller of research, Iran University of Medical Sciences
Street address
Near Milad tower, Hemmat highway
City
Tehtan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chanceller of research, Iran 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
Rasoul Akram hospital
Full name of responsible person
Parisa Hosseinpour
Position
Stager
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 930 257 7379
Fax
Email
php_111@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Parisa Hosseinpour
Position
Stager
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 930 257 7379
Fax
Email
php_111@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasoul Akram Hospital
Full name of responsible person
Parisa Hosseinpor
Position
Stager
Other areas of specialty/work
Street address
Rasool Akram Hospital, Niayesh Street, Satarkhan Street
City
Tehran
Postal code
Phone
+98 930 257 7379
Fax
Email
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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