An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section

Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section

Sponsors

Lead sponsor: Pomeranian Medical University Szczecin

Source Pomeranian Medical University Szczecin
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.

Overall Status Recruiting
Start Date September 3, 2019
Completion Date August 31, 2021
Primary Completion Date August 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative nausea and vomiting 6 hours after caesarian section. 6 hours
Postoperative nausea and vomiting 6 hours after caesarian section. 6 hours
Postoperative nausea and vomiting 6 hours after caesarian section. 6 hours
Postoperative nausea and vomiting 24 hours after caesarian section. 24 hours
Postoperative nausea and vomiting 24 hours after caesarian section. 24 hours
Postoperative nausea and vomiting 24 hours after caesarian section. 24 hours
Secondary Outcome
Measure Time Frame
Time to first peristalsis. 24 hours
Time to first bowel movement. 24 hours
Concentration of serum lactate in serum. 0 hours
Concentration of beta-hydroxy-butiric acid in serum. 0 hours
Insulin resistance factor (HOMA-IR). 0 hours
Concentration of isoprostane in urine. 0 hours
Enrollment 140
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: preoperative oral carbohydrate, preOp

Description: Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.

Arm group label: Preoperative oral carbohydrate load

Eligibility

Criteria:

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.

Gender: Female

Gender based: Yes

Gender description: Pregnant patients scheduled for planned cesarian section.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Katarzyna L Kotfis, MD, PhD Katarzyna L Kotfis, MD, PhD Katarzyna L Kotfis, MD, PhD
0048914661144 0048914661144 0048914661144
[email protected] [email protected] [email protected]
Overall Contact

Last name: Katarzyna L Kotfis, MD, PhD

Phone: 0048914661144

Email: [email protected]

Location
facility status contact
Pomeranian Medical University Recruiting Katarzyna L Kotfis, MD 0048914661144 [email protected]
Location Countries

Poland

Verification Date

September 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Pomeranian Medical University Szczecin

Investigator full name: Katarzyna Kotfis

Investigator title: Primary Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Preoperative oral carbohydrate load

Arm group type: Experimental

Description: 6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.

Arm group label: Standard preoperative fasting

Arm group type: No Intervention

Description: 6 hours for solid food and 2 hours for liquids.

Acronym POC-NaVoP
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov