Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289543
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-29
Brief Title:
Preoperative Oral Carbohydrate on Gastric Emptying
Sponsor:
Bezmialem Vakif University
Organization:
Bezmialem Vakif University
Study Overview
Official Title:
The Effect of A Newly Formulated Preoperative Oral Carbohydrate Solution on Gastric Emptying Postoperative Nausea and Vomiting and Stress Response
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current preoperative fasting guidelines recommend applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort Fasting after midnight before the operation day is a widespread practice The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product which is proven safe and efficient and unavailable in several countries In this study our objective is to analyze the gastric volume preoperative anxiety stress response postoperative insulin resistance and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa
Detailed Description:
The current preoperative fasting guidelines recommend applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort Fasting after midnight before the operation day is a widespread practice The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product which is proven safe and efficient and unavailable in several countries In this study our objective is to analyze the gastric volume preoperative anxiety stress response postoperative insulin resistance and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa
109 patients who underwent elective laparoscopic cholecystectomy aged 18-65 years and ASA physical state 1-2 were included in the study The patients were divided into 3 groups Group A who would not eat anything 6-8 hours before the operation Group S who drank 400 ml of water 2 hours before the operation and Group K which drank 400 ml preoperative oral carbohydrate solution PreOKH 2 hours before the operation Before induction of anesthesia T1 patients antral gastric cross-sectional area GKA and gastric volume GV were evaluated by gastric ultrasound The preoperative anxiety level of the patients was determined by the State-Trait Anxiety Inventory STAl before the operation T1 and the symptoms affecting the preoperative patient comfort parameters thirst hunger dry mouth fatigue were measured 2 hours before the operation T0 and before the induction T1 evaluated with the visual analog scale VAS Postoperative nausea and vomiting PONV and postoperative pain levels were recorded Blood glucose insulin and cortisol levels of the patients were measured 2 hours before the operation T0 before induction T1 and postoperative 2nd hour T3
109 patients who underwent elective laparoscopic cholecystectomy aged 18-65 years and ASA physical state 1-2 were included in the study The patients were divided into 3 groups Group A who would not eat anything 6-8 hours before the operation Group S who drank 400 ml of water 2 hours before the operation and Group K which drank 400 ml preoperative oral carbohydrate solution PreOKH 2 hours before the operation Before induction of anesthesia T1 patients antral gastric cross-sectional area GKA and gastric volume GV were evaluated by gastric ultrasound The preoperative anxiety level of the patients was determined by the State-Trait Anxiety Inventory STAl before the operation T1 and the symptoms affecting the preoperative patient comfort parameters thirst hunger dry mouth fatigue were measured 2 hours before the operation T0 and before the induction T1 evaluated with the visual analog scale VAS Postoperative nausea and vomiting PONV and postoperative pain levels were recorded Blood glucose insulin and cortisol levels of the patients were measured 2 hours before the operation T0 before induction T1 and postoperative 2nd hour T3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None