Postoperative Nausea and Vomiting
Conditions
Keywords
Nausea, Vomiting, Oral carbohydrate, Fasting
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTpreoperative oral carbohydrate, preOp
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years. 2. Scheduled for an elective cesarean section. 3. Uncomplicated pregnancy. 4. Planned for spinal anesthesia. 5. ASA I or ASA II.
Exclusion criteria
1. History of diabetes. 2. History of gastro-intestinal reflux (GERD). 3. Unable or unwilling to sign an informed consent. 4. Contraindications to spinal anesthesia. 5. Contraindication to Oral carbohydrate formula.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting 6 hours after caesarian section. | 6 hours | 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). |
| Postoperative nausea and vomiting 24 hours after caesarian section. | 24 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of serum lactate in serum. | 0 hours | Lactate level measured in maternal serum. |
| Concentration of beta-hydroxy-butiric acid in serum. | 0 hours | Beta-hydroxy-butiric acid level measured in maternal serum. |
| Time to first peristalsis. | 24 hours | Moment of first peristalsis after operation (in hours). |
| Concentration of isoprostane in urine. | 0 hours | Isoprostane level measured in maternal urine. |
| Insulin resistance factor (HOMA-IR). | 0 hours | Insulin resistance measured in maternal serum. |
| Time to first bowel movement. | 24 hours | Moment of first bowel movement after operation (in hours). |
Countries
Poland
Contacts
Primary ContactKatarzyna L Kotfis, MD, PhD
Backup ContactArleta Wojciechowska, RN
Outcome results
None listed