Protocol summary

Summary
The aim of this randomized, double-blind clinical trial is to evaluate the effect of dextrose on nausea and vomiting after laparoscopic cholecystectomy surgery in the operating room of Imam Khomeini hospital of Sari. A total 132 patients with inclusion criteria are randomized into two 66 equal groups. After establishment of monitoring of the operating room, all patients will be placed under general anesthesia with the same anesthetic technique, including midazolam 0.01 mg / kg, fentanyl 2μg / kg for Pre-medication, Propofol 2-2.5 mg / kg, cisatracurium 0.15 mg / kg for induction of anesthesia and isoflurane 1-1.5 MAC, morphine 0.1 mg / kg and 0.0 2 mg / kg cisatracurium during maintenance of anesthesia. Intravenous fluid will be standardized 3cc / kg / hr for all patients during surgery. Level of blood glucose will be measured before the start of the infusion of study solution, half an hour after the start of operation and at the beginning of the recovery with glucometer . Patients in the intervention group will receive half a liter of solution containing 5% dextrose in Ringer Lactate (Add 25 ml 50% dextrose in half a liter of Ringer lactate) and the control group will receive a half liters of ringer lactate solution. Nausea and vomiting will be asked and recorded according to the VRS, immediately and then at 30, 60, 90, 120 after recovery and then at 6, 12, 24 hours after being discharged from the recovery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504086803N9
Registration date: 2015-05-27, 1394/03/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-27, 1394/03/06
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of IV dextrose 5% on incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy
Public title
Effect of IV Dextrose on postoperative nausea and vomiting after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: (1) the desire to participate in the study, and informed consent(2) planned laparoscopic cholecystectomy surgery (3) age between 18-65 years. Exclusion criteria included: (1) At any time based on the patient's unwillingness to continue participating in study (2) Systemic hypertension (blood pressure above the 140/90 mm-Hg in two or more measurements(3) renal failure(4) coagulopathy (5)chronic heart failure, (6)liver failure(7) Diabetes mellitus (fasting morning glucose levels over 100 mg / dl)(8) previous history of severe nausea and vomiting after surgery (9)pregnancy(10) surgery prolonged more than 2 hours.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
sari
Postal code
4817844718
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
28/8/1393

Health conditions studied

1

Description of health condition studied
postoperative nausea and vomiting after laparoscopic cholecystectomy
ICD-10 code
k91.0
ICD-10 code description
Vomiting following gastrointestinal surgery

Primary outcomes

1

Description
incidence of nausea and vomiting
Timepoint
immediately and at 30, 60, 90, 120 after recovery and at 6, 12, 24 hours after being discharged from the recovery
Method of measurement
yes/no and Record in Questionnaire

Secondary outcomes

1

Description
intensity of nausea and vomiting
Timepoint
immediately and at 30, 60, 90, 120 after recovery and at 6, 12, 24 hours after being discharged from the recovery
Method of measurement
VRS(visual rating scale) and Record in Questionnaire

2

Description
use of antiemetics
Timepoint
during 24 hours after surgery
Method of measurement
mg(miligram) and record in questionnaire

Intervention groups

1

Description
infusion of 500cc solution containing 5% dextrose in Ringer Lactate whithin 30 minutes before induction of anesthesia
Category
Treatment - Drugs

2

Description
infusion of 500cc solution containing Ringer Lactate whithin 30 minutes and before induction of anesthesia
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospita
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
SARI
Grant name
10506
Grant code / Reference number
28/8/1393
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam khomeini hospital, Amir mazandarani Ave.
City
SARI
Postal code
4814839953
Phone
+98 11 3337 5038
Fax
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
sari
Postal code
4814839953
Phone
+98 11 3337 5038
Fax
+98 11 3337 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Montazami MD
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 11 3337 5038
Fax
+98 11 3337 5038
Email
maryam.montazami@gmail.com
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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