Evaluating of the Effect of Oral Administration of Sugar Solution on Intraoperative and Postoperative Blood Glucose Levels in Patients Undergoing Major Gynecological Surgery
To determine the effect of preoperative oral carbohydrate solution on postoperative blood glucose levels in patients undergoing major gynecological surgery
Design
Randomized, double blind, placebo controlled, parallel group clinical trial on 60 patients; randomization was performed using a random number table
Settings and conduct
This single center study is conducted at Shahid Sadoughi Hospital in Yazd. After obtaining informed consent, patients are randomly assigned to two groups. Both patients and outcome assessors are blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 16 to 60 years undergoing major gynecological surgery; American Society of Anesthesiologists physical status class II. Exclusion criteria: American Society of Anesthesiologists class III or higher; history of type 1 or type 2 diabetes mellitus; recent hospitalization within the past two months with dextrose infusion; inability to tolerate oral intake.
Intervention groups
Intervention group: Receiving 100 ml of 50% oral dextrose solution two hours prior to surgery.
Control group: Receiving 100 ml of plain oral water as placebo two hours prior to surgery.
Main outcome variables
Blood glucose level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002963N45
Registration date:2026-09-27, 1405/07/05
Registration timing:prospective
Last update:2026-09-27, 1405/07/05
Update count:0
Registration date
2026-09-27, 1405/07/05
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2027-01-21, 1405/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of the Effect of Oral Administration of Sugar Solution on Intraoperative and Postoperative Blood Glucose Levels in Patients Undergoing Major Gynecological Surgery
Public title
Evaluation of the Effect of Oral Sugar Solution Administration on Blood Glucose Levels in Gynecological Surgery Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women aged 16–60 years classified as ASA Physical Status II who are scheduled to undergo major gynecological surgery
Exclusion criteria:
All women aged 16–60 years classified as ASA Physical Status III or higher who are scheduled to undergo major gynecological surgery
A diagnosis of either type 1 or type 2 diabetes mellitus
Hospitalization within the preceding two months, accompanied by the administration of intravenous dextrose-containing fluids
Withdrawal of the patient or her accompanying person from further participation in the study
Development of complications related to postoperative hypoglycemia or hyperglycemia
Inability to tolerate oral intake for a prolonged period
Age
From 16 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome assessors are blinded to the intervention received (sugar solution or water).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Faculty of Medicine. Shohadayegomnam Blv.Yazd
City
yazd
Province
Yazd
Postal code
8915887857
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403.378
Health conditions studied
1
Description of health condition studied
Elevated blood glucose level
ICD-10 code
R73
ICD-10 code description
Elevated blood glucose level
Primary outcomes
1
Description
Blood glucose level (in milligrams per deciliter)
Timepoint
Before intervention (baseline), at the end of surgery, 1 hour after the end of surgery, and 6 hours after the end of surgery
Method of measurement
Blood glucose monitoring device (Glucometer)
Secondary outcomes
1
Description
Postoperative pain intensity
Timepoint
1 hour and 6 hours after the end of surgery
Method of measurement
Visual Analogue Scale (score 0 to 10)
Intervention groups
1
Description
Intervention group: Patients receive 100 ml of 50% oral dextrose solution two hours before surgery and then undergo major gynecological surgery under general anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Patients receive 100 ml of water two hours before surgery and then undergo major gynecological surgery under general anesthesia.