- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05005091
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients (oralcarbohydra)
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
The study was conducted on 94 patients. The patients in the control group were fasting after midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before the operation. 47 patients were in the control group (A) and 47 patients were in the experimental group (B). The groups were compared in terms of length of hospital and intensive care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation parameters, blood glucose, and mobilization time.
SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test were used. In addition, correlation analysis was used to determine the relationship between fasting time and surgical recovery time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34857
- health Science University, Sureyyapa Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Stage I-Stage II all operable NSCLC patients -
Exclusion Criteria:
Patients with diabetes mellitus, a history of delayed gastric emptying, severe hepatic or renal failure, or any endocrine disorder that might influence the metabolic parameters were excluded, as were patients requiring urgent or emergent surgery.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: oral carbohydrate
the patients drunk oral carbohydrate two hours ago preoperatively
|
100 ml oral carbohydrate two hours ago preoperatively
|
|
No Intervention: no oral carbohydrate
the patients did not drink oral carbohydrate preoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobilization time
Time Frame: 1 hour
|
postoperative mobilization
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SureyyapasaM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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