Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section (POC-NaVoP)
Primary Purpose
Postoperative Nausea and Vomiting
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
preoperative oral carbohydrate, preOp
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Nausea, Vomiting, Oral carbohydrate, Fasting
Eligibility Criteria
Inclusion Criteria:
- Age >=18 years.
- Scheduled for an elective cesarean section.
- Uncomplicated pregnancy.
- Planned for spinal anesthesia.
- ASA I or ASA II.
Exclusion Criteria:
- History of diabetes.
- History of gastro-intestinal reflux (GERD).
- Unable or unwilling to sign an informed consent.
- Contraindications to spinal anesthesia.
- Contraindication to Oral carbohydrate formula.
Sites / Locations
- Pomeranian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preoperative oral carbohydrate load
Standard preoperative fasting
Arm Description
6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.
6 hours for solid food and 2 hours for liquids.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Time to first peristalsis.
Moment of first peristalsis after operation (in hours).
Time to first bowel movement.
Moment of first bowel movement after operation (in hours).
Concentration of serum lactate in serum.
Lactate level measured in maternal serum.
Concentration of beta-hydroxy-butiric acid in serum.
Beta-hydroxy-butiric acid level measured in maternal serum.
Insulin resistance factor (HOMA-IR).
Insulin resistance measured in maternal serum.
Concentration of isoprostane in urine.
Isoprostane level measured in maternal urine.
Full Information
NCT ID
NCT04069806
First Posted
August 23, 2019
Last Updated
September 14, 2020
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT04069806
Brief Title
Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
Acronym
POC-NaVoP
Official Title
An Analysis of Risk Factors and Implementation of Strategies to Prevent Nausea and Vomiting in Patients Undergoing Regional Anesthesia for Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Nausea, Vomiting, Oral carbohydrate, Fasting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative oral carbohydrate load
Arm Type
Experimental
Arm Description
6 hours for solid food and 2 hours for liquids + oral carbohydrate preparation 2 hours prior to surgery.
Arm Title
Standard preoperative fasting
Arm Type
No Intervention
Arm Description
6 hours for solid food and 2 hours for liquids.
Intervention Type
Dietary Supplement
Intervention Name(s)
preoperative oral carbohydrate, preOp
Intervention Description
Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting 6 hours after caesarian section.
Description
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
Title
Postoperative nausea and vomiting 24 hours after caesarian section.
Description
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
Secondary Outcome Measure Information:
Title
Time to first peristalsis.
Description
Moment of first peristalsis after operation (in hours).
Time Frame
24 hours
Title
Time to first bowel movement.
Description
Moment of first bowel movement after operation (in hours).
Time Frame
24 hours
Title
Concentration of serum lactate in serum.
Description
Lactate level measured in maternal serum.
Time Frame
0 hours
Title
Concentration of beta-hydroxy-butiric acid in serum.
Description
Beta-hydroxy-butiric acid level measured in maternal serum.
Time Frame
0 hours
Title
Insulin resistance factor (HOMA-IR).
Description
Insulin resistance measured in maternal serum.
Time Frame
0 hours
Title
Concentration of isoprostane in urine.
Description
Isoprostane level measured in maternal urine.
Time Frame
0 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant patients scheduled for planned cesarian section.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >=18 years.
Scheduled for an elective cesarean section.
Uncomplicated pregnancy.
Planned for spinal anesthesia.
ASA I or ASA II.
Exclusion Criteria:
History of diabetes.
History of gastro-intestinal reflux (GERD).
Unable or unwilling to sign an informed consent.
Contraindications to spinal anesthesia.
Contraindication to Oral carbohydrate formula.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna L Kotfis, MD, PhD
Phone
0048914661144
Email
katarzyna.kotfis@pum.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Arleta Wojciechowska, RN
Email
arletawoj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna L Kotfis, MD, PhD
Organizational Affiliation
Pomeranian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastian Kwiatkowski, MD, PhD
Organizational Affiliation
Pomeranian Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna L Kotfis, MD
Phone
0048914661144
Email
katarzyna.kotfis@pum.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
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