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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative oral carbohydrate load | Experimental | 6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery. |
|
| Standard preoperative fasting | No Intervention | 6 hours for solid food and 2 hours for liquids. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative oral carbohydrate, preOp | Dietary Supplement | Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first peristalsis. | Moment of first peristalsis after operation (in hours). | 24 hours |
| Time to first bowel movement. | Moment of first bowel movement after operation (in hours). |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant patients scheduled for planned cesarian section.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna L Kotfis, MD, PhD | Contact | 0048914661144 | katarzyna.kotfis@pum.edu.pl | |
| Arleta Wojciechowska, RN | Contact | arletawoj@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Katarzyna L Kotfis, MD, PhD | Pomeranian Medical University | Principal Investigator |
| Sebastian Kwiatkowski, MD, PhD | Pomeranian Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pomeranian Medical University | Recruiting | Szczecin | 70-111 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40348958 | Derived | Kotfis K, Jamiol-Milc D, Wojciechowska A, Szylinska A, Drozd A, Zimny M, Dolegowska B, Kwiatkowski S, Dziedziejko V, Safranow K. Maternal and umbilical cord plasma purine concentrations after oral carbohydrate loading prior to elective Cesarean delivery under spinal anesthesia: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 May 10;25(1):556. doi: 10.1186/s12884-025-07637-6. | |
| 37568381 |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| 24 hours |
| Concentration of serum lactate in serum. | Lactate level measured in maternal serum. | 0 hours |
| Concentration of beta-hydroxy-butiric acid in serum. | Beta-hydroxy-butiric acid level measured in maternal serum. | 0 hours |
| Insulin resistance factor (HOMA-IR). | Insulin resistance measured in maternal serum. | 0 hours |
| Concentration of isoprostane in urine. | Isoprostane level measured in maternal urine. | 0 hours |
| Derived |
| Kotfis K, Wojciechowska A, Zimny M, Jamiol-Milc D, Szylinska A, Kwiatkowski S, Kaim K, Dolegowska B, Stachowska E, Zukowski M, Pankowiak M, Torbe A, Wischmeyer P. Preoperative Oral Carbohydrate (CHO) Supplementation Is Beneficial for Clinical and Biochemical Outcomes in Patients Undergoing Elective Cesarean Delivery under Spinal Anaesthesia-A Randomized Controlled Trial. J Clin Med. 2023 Jul 28;12(15):4978. doi: 10.3390/jcm12154978. |
| D012816 | Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |