An interventional study of preoperative oral carbohydrate, preOp in Postoperative Nausea and Vomiting, sponsored by Pomeranian Medical University Szczecin. Status unknown at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Pomeranian Medical University Szczecin · Not applicable, Interventional, and Prevention
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. The aim of this study is to compare the effectiveness of oral carbohydrate loading to standard pre-operative fasting in patients undergoing elective cesarean section on the incidence and severity of PONV and biochemical parameters indicating ketosis.
Post-operative nausea and vomiting (PONV) in women undergoing subarachnoid anesthesia for Caesarean section is an important clinical problem. Known mechanisms underlying PONV are based on prolonged fasting, hypotension due to concomitant sympatholysis during anesthesia, bradycardia due to increased vagal tone, visceral stimulation during surgery and intrathecal administered opioids. However, the identification of patients exposed to this problem and appropriate perioperative preparation is of key importance. An analysis of risk factors for postoperative nausea and vomiting in patients undergoing elective cesarean section under spinal anesthesia is of major clinical importance. The aim of this study is a comparison of the effectiveness of oral carbohydrate loading strategy as compared with standard pre-operative fasting in patients undergoing elective cesarean section under spinal anesthesia on the incidence and severity of PONV and biochemical parameters indicating ketosis.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 140 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Pomeranian Medical University Szczecin is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.
Dietary Supplement: preoperative oral carbohydrate, preOp
6 hours for solid food and 2 hours for liquids.
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
Postoperative nausea and vomiting 6 hours after caesarian section.
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 6 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
Time frame: 6 hours
Postoperative nausea and vomiting 24 hours after caesarian section.
The Postoperative Nausea and Vomiting (PONV) Intensity Scale 24 hours after caesarian section. Scale range: 0-50. The scale measures PONV intensity, where a score ≥50 defined clinically important PONV: PONV Intensity Scale=severity of nausea (1=mild, 2=moderate, 3=severe)×pattern of nausea (1=varying, 2=constant)×duration of nausea (in hours).
Time frame: 24 hours
Time to first peristalsis.
Moment of first peristalsis after operation (in hours).
Time frame: 24 hours
Time to first bowel movement.
Moment of first bowel movement after operation (in hours).
Time frame: 24 hours
Concentration of serum lactate in serum.
Lactate level measured in maternal serum.
Time frame: 0 hours
Concentration of beta-hydroxy-butiric acid in serum.
Beta-hydroxy-butiric acid level measured in maternal serum.
Time frame: 0 hours
Insulin resistance factor (HOMA-IR).
Insulin resistance measured in maternal serum.
Time frame: 0 hours
Concentration of isoprostane in urine.
Isoprostane level measured in maternal urine.
Time frame: 0 hours
Plan to share: No
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Pomeranian Medical University Szczecin