Postoperative nausea and vomiting (PONV) remains one of the most common postoperative complications. The aim of the present study is to evaluate the effect of infusion iv dextrose solution beginning with the start of surgery to end of operation for prophylaxis of PONV in patients undergoing diagnostic gynecologic laparoscopy under general anesthesia. In this clinical trial 70 ASA physical status I non-diabetic patients and aged 20-70 years, scheduled for diagnostic gynecologic laparoscopy are randomly assigned to infusion of 10 mL/kg/h Ringer’s solution with 0.5 g/kg dextrose in study group ( n = 35) or Ringer’s solution alone in placebo group ( n = 35) during surgery. Blood glucose is determined using a glucometer in the operating room immediately before study fluid infusion and in the recovery room. PONV scores using by (0= non; 1= nausea; 2=vomiting; and 3= vomiting > 3 times) scoring in recovery room and at 3, 6, and 24 hours postoperatively, first request to antiemetic , and total dose of antiemetic medication are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402047013N10
Registration date:2014-02-10, 1392/11/21
Registration timing:na
Last update:
Update count:0
Registration date
2014-02-10, 1392/11/21
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Not enough for processing
Funding source
Research Vice Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-30, 1392/10/09
Expected recruitment end date
2013-12-29, 1392/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Intraoperative Dextrose Infusion for Prevention of Nausea and Vomiting after Diagnostic Gynecologic Laparoscopy
Public title
Effect of Intraoperative Dextrose Infusion for Prevention of Nausea and Vomiting after Diagnostic Gynecologic Laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 20-40 years; ASA class 1; scheduled for diagnostic gynecologic laparoscopy
Exclusion criteria: vaginal hemorrhage; taking any medication, including corticosteroids , opioids and antiemetics; history of systemic disease( cardiovascular, respiratory, renal ,…); history of motion sickness; history of gastrointestinal disease; pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Research Vice Chancellor, Tabriz University of Medical Sciences
Street address
Research Vice Chanceller; Tabriz University; Daneshgah Street; Tabriz
City
Tabriz
Postal code
Approval date
2013-12-30, 1392/10/09
Ethics committee reference number
92164
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
Severity of postoperative nausea and vomiting
Timepoint
Recovery and at 3, 6, and 24 h postoperatively
Method of measurement
scoring by (0=non, 1=nausea, 2=vomiting, 3=vomiting >2 times)
Secondary outcomes
1
Description
Total dose of antiemetic
Timepoint
recavery and during 24 hpostoperatively
Method of measurement
mg
Intervention groups
1
Description
In the study group is infused 10 ml/kg/h Ringer’s solution with 0.5 g/kg dextrose during surgery.
Category
Prevention
2
Description
In the placebo group (n=35) is infused of 10 ml/kg/h Ringer’s solution alone in placebo during surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Alzahra Hospital, South Artesh Ave, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor, Daneshgah Street, Tabriz
Full name of responsible person
Dr. Rashidi
Street address
Research Vice Chancellor, Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor, Daneshgah Street, Tabriz
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr.Simin Atashkhoyi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)