Postoperative nausea and vomiting (PONV) remains one of the most common postoperative complications. The aim of the present study is to determine the Efficacy of preoperative dextrose infusion on postoperative nausea and vomiting. In this clinical trial 300 ASA physical status I non-diabetic patients and aged 18-40 years, scheduled for open surgeries are randomly assigned to infusion of 10 ml/kg/h Ringer’s solution with 100 mL/h dextrose 10% in study group (n = 150) or Ringer’s solution alone in placebo group (n = 150) during surgery. 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 cisatracurium during maintenance of anesthesia. PONV scores using by Visual Analogue Scale (VAS) and (Nausea and vomiting in slight level is zero to 3, in average level is 3 to 7 and in severe level is more than 7) scoring in recovery room and at 0, 30, 60, 120 minute and 4 hours postoperative are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015032721544N1
Registration date:2015-06-21, 1394/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-21, 1394/03/31
Registrant information
Name
Saeed Khazaei Jalil
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 6269
Email address
khazaei@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative dextrose infusion on postoperative nausea and vomiting
Public title
The effect of dextrose infusion on postoperative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1; both sexes; aged 18 to 40 years; Open surgeries that are identical in terms of time and type of anesthesia.
Exclusion criteria: diabetics; history of systemic disease (cardiovascular, respiratory, renal ,…); history of nausea and vomiting.
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
298
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, Vice chancellor for research, Shahroud University of Medical Sciences
Street address
Ethics committee, Vice chancellor for research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud, Iran. Postal code: 3614773955
City
Shahroud
Postal code
3613773955
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
IR.SHMU.REC.1394.17
Health conditions studied
1
Description of health condition studied
Postoperative Nausea and Vomiting
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Intensity of Postoperative Nausea and Vomiting
Timepoint
0 (while the patient is awake), 30, 60, 120 minute and 4 hours after the surgery.
Method of measurement
Questionnaire- Visual Analog Scale
Secondary outcomes
1
Description
Total dose antiemetic drug
Timepoint
Recovery within 24 hours after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
In the study group (n=150) is infused 10 ml/kg/h Ringer’s solution with 100 mL/h dextrose 10% during surgery.
Category
Prevention
2
Description
In the placebo group (n=150) is infused of 10 ml/kg/h Ringer’s solution alone in placebo during surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Operation room, Imam Hossein hospital
Full name of responsible person
Javad Nourian MD
Street address
Imam Hossein Hospital, operation room, End of Towhidi avenue
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian MD
Street address
Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud 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
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2001
Fax
+98 27 3333 3902
Email
javadnourian@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2001
Fax
+98 27 3333 3902
Email
javadnourian@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Saeed Khazaei Jalil
Position
Operating Room student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 6269
Fax
Email
Khazaei@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)